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Hand sanitizer

Hand sanitizer, also known as hand antiseptic or handrub, is a topical product designed to reduce the number of microorganisms on the hands when soap and water are not available. It is typically formulated as a gel, liquid, foam, or wipe and serves as a convenient alternative for hand hygiene, particularly in healthcare settings, public spaces, and during outbreaks of infectious diseases.^[1]^[2] The most common type, alcohol-based hand sanitizer (ABHS), contains ethanol (ethyl alcohol) or isopropanol (isopropyl alcohol) at concentrations of 60% to 95% as the active ingredient, which denatures proteins and disrupts cell membranes in bacteria, viruses, and fungi to achieve rapid antimicrobial action. Inactive ingredients often include water, glycerin for moisturizing, and fragrances or emollients to improve usability and prevent skin dryness. Non-alcohol-based options exist, such as those with benzalkonium chloride, but they are less effective against certain viruses and are not recommended as primary alternatives by health authorities. ABHS products are regulated as over-the-counter drugs in many countries, requiring specific alcohol levels for efficacy and safety.^[3]^[4]^[5] Hand sanitizers gained prominence in the late 20th century, with commercial products such as Purell introduced by GOJO Industries in 1988 for broader use. Their importance surged during the COVID-19 pandemic, when they became a key tool in preventing the spread of SARS-CoV-2, alongside handwashing, as recommended by global health organizations. Studies confirm that proper use of ABHS can reduce hand contamination by up to 99.9% for many pathogens, though they are less effective against certain non-enveloped viruses or when hands are visibly soiled.^[6]^[1]^[7]

Overview

Definition and purpose

Hand sanitizer is a topical antiseptic product formulated as a gel, foam, or liquid that is applied to the hands to reduce the number of microorganisms, including bacteria and viruses, on the skin surfaces.^[8] These products are designed for use without water and serve as an alternative for hand hygiene when soap and running water are not accessible.^[1] The term "hand sanitizer" first appeared in the 1960s, with common alternative names including hand rub, hand antiseptic, and hand disinfectant.^[9] The primary purpose of hand sanitizer is to provide rapid disinfection by killing or inactivating transient microorganisms—those temporarily present on the skin from external contact—thereby helping to prevent the spread of infections.^[10] It targets pathogens such as bacteria and enveloped viruses but is most effective against certain types when formulated appropriately.^[11] Hand sanitizers are particularly useful in settings like healthcare facilities, public transportation, or during travel, where immediate hand cleaning is needed to maintain hygiene.^[2] Effective hand hygiene fundamentally involves the mechanical removal or chemical inactivation of germs to break the chain of infection transmission.^[12] While hand sanitizers supplement this process by quickly reducing microbial load on clean hands, they do not replace handwashing with soap and water, which physically removes dirt, oils, and a broader spectrum of germs, including spores and non-enveloped viruses.^[1] Sanitizers are recommended only when hands are not visibly soiled, as visible dirt can reduce their efficacy.^[13]

History

The concept of hand hygiene in medical settings traces back to the mid-19th century, when Hungarian physician Ignaz Semmelweis demonstrated in 1847 that washing hands with a chlorinated lime solution significantly reduced puerperal fever mortality rates in maternity wards from 18% to under 2%, laying foundational principles for antiseptic practices that later evolved to include alcohol-based agents.^[14] Alcohol had been recognized for its antiseptic properties since the late 19th century, with early 20th-century developments focusing on its use in surgical preparations and wound care, though portable, waterless formulations for routine hand disinfection remained undeveloped until the mid-20th century.^[14] Commercialization of hand sanitizers began in the 1940s and 1960s, driven by industrial and healthcare needs. In 1946, Goldie and Jerry Lippman founded GOJO Industries and developed the first commercial waterless hand cleaner using petroleum-based solvents and emollients, initially targeted at mechanics in rubber factories to remove grease without water.^[6]^[15] This was followed in 1965 by Sterillium, the world's first marketable alcohol-based hand rub, created by Hartmann Group in Germany under the guidance of surgeon Peter Kalmár, featuring 45% 2-propanol, 30% n-propanol, and mecetronium ethylsulfate for rapid disinfection in surgical settings.^[16] By 1988, GOJO introduced Purell, an ethanol-based gel sanitizer (62% ethyl alcohol) designed for healthcare workers, marking a shift toward convenient, gel-form products that minimized skin irritation compared to liquid alcohols. Purell was notable as one of the first gel-based formulations, which helped prevent rapid evaporation of the alcohol and reduced skin dryness compared to liquid versions.^[6]^[17] Adoption remained limited in the pre-2000s era due to high production costs, lack of widespread awareness, and regulatory uncertainties, confining use primarily to hospitals and laboratories. The U.S. Food and Drug Administration (FDA) advanced acceptance through its 1994 Tentative Final Monograph for Over-the-Counter Topical Antimicrobial Drug Products, which proposed conditions for alcohol-based hand antiseptics as safe and effective for healthcare personnel hand antisepsis.^[18] In the 1990s, the World Health Organization (WHO) expressed growing interest in low-cost alcohol-based formulations to improve hand hygiene in resource-limited developing countries, where access to water and soap was often inadequate, setting the stage for global standardization efforts.^[17] Post-2000 developments accelerated growth, with the Centers for Disease Control and Prevention (CDC) endorsing alcohol-based rubs as the preferred method for hand hygiene in healthcare settings in its 2002 guidelines, leading to broader FDA approvals and formulations meeting efficacy standards.^[19] This regulatory support, combined with increasing evidence of efficacy against pathogens, fueled expansion into consumer markets during the 2010s, where sales grew from niche healthcare products to everyday items, with the U.S. market surpassing $400 million by 2015 amid rising public health awareness.^[20] Alcohol remained the core active ingredient, typically at 60-95% concentration, enabling quick-drying, no-rinse application.^[17]

Types

Alcohol-based

Alcohol-based hand sanitizers primarily utilize ethanol or isopropanol as active agents to achieve antimicrobial effects. These formulations work by denaturing proteins and disrupting cell membranes in bacteria and viruses, leading to the loss of microbial function and integrity.^[21]^[22] This mechanism is most effective at alcohol concentrations ranging from 60% to 95% by volume, as lower levels fail to sufficiently penetrate and coagulate microbial structures, while higher concentrations may evaporate too quickly to act fully.^[23]^[24] Two common variants dominate: ethanol-based sanitizers, which are preferred due to their lower toxicity upon accidental ingestion, and isopropanol-based ones, which evaporate more rapidly but carry a stronger, more pungent odor.^[25]^[26] Ethanol formulations, such as the World Health Organization's recommended 80% ethanol preparation, are widely adopted for their balance of efficacy and safety in broad applications.^[17] These sanitizers are available in multiple physical forms to suit different usage scenarios: gels, which incorporate thickeners like carbomer for better adhesion and controlled application on hands; foams, designed for even distribution and easier spreading without dripping; and liquids, offering simplicity and rapid absorption.^[27]^[28] Key advantages include broad-spectrum antimicrobial activity against Gram-positive and Gram-negative bacteria, fungi, and enveloped viruses, alongside quick-drying properties that leave no residue, enabling immediate use of hands post-application.^[21]^[29]^[30]

Alcohol-free

Alcohol-free hand sanitizers employ non-alcohol antimicrobial agents to reduce microbial load on the skin. The primary active ingredients are quaternary ammonium compounds (quats), such as benzalkonium chloride and benzethonium chloride, which serve as cationic surfactants effective at low concentrations (typically 0.1-0.2%). Triclosan, another formerly common agent, has been phased out in consumer products in regions like the United States following regulatory restrictions on its use in over-the-counter antiseptics due to safety and environmental concerns.^[31]^[2]^[32] These agents exert their antimicrobial effects primarily through disruption of microbial cell membranes, causing leakage of intracellular contents and eventual cell death, while some also inhibit key enzymes and denature proteins within the cell. This mechanism contrasts with the rapid protein denaturation of alcohol-based sanitizers and often necessitates a longer contact time—typically 30 seconds to 2 minutes—for optimal efficacy against bacteria and enveloped viruses.^[33]^[34]^[35] Alcohol-free sanitizers find niche applications in settings where alcohol use is restricted, such as near open flames or in flammable environments, owing to their non-volatile and non-flammable formulations. They are also favored for individuals with sensitive or dry skin, as they incorporate moisturizers and cause less irritation or lipid depletion compared to alcohol-based alternatives. Moreover, quats provide residual antimicrobial persistence on skin and surfaces, extending protection beyond the initial application.^[30]^[36]^[37] A key limitation of alcohol-free sanitizers is the potential for bacterial adaptation and resistance to quats, which can enhance cross-resistance to antibiotics through mechanisms like efflux pump overexpression. Additionally, they exhibit reduced effectiveness against non-enveloped viruses, such as norovirus, compared to enveloped viruses like SARS-CoV-2. In contrast to alcohol-based sanitizers, which act more rapidly on a broader viral spectrum, alcohol-free options prioritize persistence over speed.^[38]^[5]^[39]

Composition

Active ingredients

Hand sanitizers primarily rely on active ingredients that disrupt microbial cell membranes and denature proteins to achieve antimicrobial effects. The most common active ingredients are alcohols, specifically ethanol (ethyl alcohol) and isopropanol (isopropyl alcohol), which are effective against a broad spectrum of bacteria, viruses, and fungi when used at appropriate concentrations.^[2]^[1] Ethanol is typically formulated at concentrations of 60% to 95% by volume in hand sanitizers to ensure efficacy, with the U.S. Centers for Disease Control and Prevention (CDC) recommending a minimum of 60% for virucidal activity against enveloped viruses like SARS-CoV-2.^[1]^[3] Isopropanol is used at 70% to 91.3% by volume, offering similar antimicrobial properties but with a faster evaporation rate that can enhance skin tolerance in some formulations.^[40] To prevent ingestion and misuse, ethanol in hand sanitizers is often denatured with additives such as tert-butanol (tert-butyl alcohol), which imparts a bitter taste without compromising the alcohol's antimicrobial action. The World Health Organization (WHO) specifies formulations with 80% ethanol or 75% isopropanol as optimal for broad-spectrum activity, emphasizing that concentrations below these thresholds may reduce effectiveness against certain pathogens.^[41] Non-alcohol active ingredients are used in alcohol-free hand sanitizers, particularly in settings where alcohol is unsuitable, such as near open flames or for individuals with alcohol sensitivities. Benzalkonium chloride, a quaternary ammonium compound, is the primary non-alcohol antimicrobial, typically at concentrations of 0.1% to 0.2% by weight, where it acts by disrupting bacterial cell membranes.^[2] Chlorhexidine gluconate, effective against gram-positive bacteria and some viruses, is incorporated in some formulations at 0.5% to 4%, often combined with alcohol for enhanced persistence on skin.^[42] Povidone-iodine, which releases free iodine to oxidize microbial proteins, is used in specialized hand rubs at concentrations around 1% to 10%, though it is less common in consumer products due to potential skin staining.^[43] To mitigate the drying effects of active ingredients like alcohols, synergistic additives such as glycerin (at approximately 1.45% in WHO formulations) or aloe vera are included, which help maintain skin hydration without interfering with antimicrobial performance.^[41] These components ensure the sanitizer remains gentle for repeated use while preserving the core disinfecting properties.^[44]

Standard formulations

Standard formulations for hand sanitizers are established through international and national guidelines to ensure efficacy, safety, and consistency in production, particularly for alcohol-based products. The World Health Organization (WHO) provides two recommended formulations for local production, designed to be simple, cost-effective, and suitable for use in healthcare and community settings where commercial products may be unavailable.^[41] WHO Formulation I uses ethanol as the primary active ingredient and is prepared for a batch yielding approximately 1000 ml of final product. It consists of 80% v/v ethanol (833.3 ml of 96% v/v ethanol), 1.45% v/v glycerol (14.5 ml of 98% glycerol), and 0.125% v/v hydrogen peroxide (41.7 ml of 3% H₂O₂), with the volume topped up to 1000 ml using distilled or boiled and cooled water. Preparation involves pouring the ethanol into a graduated flask, adding the hydrogen peroxide, then the glycerol, topping up with water, and gently shaking to mix; all ingredients must be of pharmacopoeial quality to minimize contamination risks. The formulation is stored in a cool, well-ventilated area away from ignition sources due to its flammability (flash point of 17.5°C), with production limited to 50 liters per batch to ensure quality control.^[17]^[41] WHO Formulation II serves as an alternative when ethanol is scarce or unavailable, substituting isopropyl alcohol while maintaining similar additive concentrations for skin protection and microbial spore inactivation. It includes 75% v/v isopropyl alcohol (751.5 ml of 99.8% purity isopropyl alcohol), 1.45% v/v glycerol, and 0.125% v/v hydrogen peroxide, topped up to 1000 ml with distilled or boiled and cooled water. The preparation steps mirror Formulation I: add isopropyl alcohol to the flask, followed by hydrogen peroxide, glycerol, water, and gentle mixing. Storage requirements are comparable, with a flash point of 19°C and the same batch size limit; this formulation is particularly useful in resource-limited settings where isopropyl alcohol may be more accessible from industrial sources.^[17]^[41] In the United States, the Food and Drug Administration (FDA), aligning with Centers for Disease Control and Prevention (CDC) recommendations, requires alcohol-based hand sanitizers to contain a minimum of 60% ethanol or 70% isopropyl alcohol for efficacy, exercising enforcement discretion for compliant products marketed as over-the-counter antiseptics. These concentrations ensure broad-spectrum antimicrobial activity while allowing for variations in inactive ingredients like emollients, but products must comply with good manufacturing practices for OTC distribution.^[45] The European Norm EN 1500 provides a standardized testing protocol for hygienic hand rubs, evaluating their ability to reduce transient bacterial flora on hands by at least 5 log₁₀ units within 60 seconds of application, typically using alcohol concentrations of 60-80% to meet the criteria. This norm focuses on efficacy validation rather than prescribing exact formulations but influences European product standards by requiring compliance for market approval as surgical or hygienic rubs. For resource-limited settings, WHO formulations are adapted to prioritize low-cost sourcing, such as using locally available technical-grade alcohols tested for purity (e.g., absence of methanol), with quality control steps including pH adjustment to 5.5-7.0 and visual inspection for clarity. These adaptations emphasize simple equipment like graduated flasks and avoid complex machinery, enabling production in pharmacies or small facilities while maintaining safety through small-batch limits and proper labeling.^[41]

Effectiveness

Against microorganisms

Hand sanitizers, particularly alcohol-based formulations, demonstrate broad-spectrum antimicrobial activity against enveloped viruses such as SARS-CoV-2 and influenza A (H1N1), achieving significant inactivation within short contact times.^[5] Ethanol at concentrations of 80% or higher inactivates all tested enveloped viruses, including coronaviruses and influenza strains, by disrupting their lipid envelopes.^[46] These products are also highly effective against both Gram-positive and Gram-negative bacteria, such as Escherichia coli and Staphylococcus aureus, with reductions exceeding 5 log₁₀ (equivalent to over 99.999% kill rates) observed in multiple species within 15 seconds of application.^[47] However, efficacy diminishes against non-enveloped viruses like norovirus, where alcohol-based sanitizers show limited virucidal activity compared to soap and water.^[1] Similarly, they exhibit poor performance against bacterial spores, including those of Clostridioides difficile, failing to remove or inactivate them effectively even in laboratory settings.^[13] Standardized testing protocols quantify this antimicrobial performance through log reductions in microbial counts. The European standard EN 1500 evaluates hygienic hand rubs by requiring at least a 5-log₁₀ reduction in transient bacterial counts, such as E. coli, on artificially contaminated hands after a 60-second application, serving as a benchmark for regulatory approval in many regions.^[48] For viral efficacy, while ASTM E1115 primarily assesses bacterial reductions in surgical hand scrub formulations (typically achieving 1-2 log₁₀ immediate effects), complementary standards like EN 14476 measure virucidal activity, demanding a 4-log₁₀ reduction against enveloped viruses to confirm broad efficacy.^[49] Several factors influence the antimicrobial outcomes of hand sanitizers. A minimum contact time of 20-30 seconds is recommended by the World Health Organization to ensure thorough coverage and drying, as shorter durations may reduce log reductions by up to 50% for certain pathogens.^[50] Alcohol concentration is critical, with optimal bactericidal and virucidal effects occurring between 60% and 90% (v/v), where lower levels fail to denature proteins effectively and higher ones evaporate too rapidly.^[51] Additionally, the presence of organic soil load, such as dirt or bodily fluids, can impair efficacy by binding to active ingredients, potentially halving log reductions in contaminated scenarios.^[52] Key clinical and laboratory studies underscore these effects. In vivo trials using alcohol-based gels (70-85% ethanol) demonstrated 99.9% (3-log₁₀) reductions in H1N1 influenza A virus on human hands after 20-40 seconds of application, outperforming non-alcohol alternatives in direct comparisons.^[53] Against methicillin-resistant Staphylococcus aureus (MRSA), a single 2 mL application of alcohol gel consistently achieved over 99% reduction in viable counts, though incomplete elimination occurred in some cases due to skin residues.^[54] These findings, from peer-reviewed evaluations, highlight the role of hand sanitizers in rapid pathogen control when used correctly.

Limitations and comparisons

Hand sanitizers, particularly alcohol-based formulations, exhibit significant limitations in scenarios involving visible dirt, feces, or heavy soils, as they lack the mechanical action necessary for physical removal of contaminants. In such cases, handwashing with soap and water is recommended to effectively dislodge and eliminate these materials, whereas sanitizers may fail to penetrate or address soiled surfaces adequately.^[10]^[1] Alcohol-based hand sanitizers are also ineffective against certain resilient pathogens, such as norovirus and the spores of Clostridioides difficile, which require alternative interventions like soap and water or bleach-based disinfectants for elimination. Norovirus, a non-enveloped virus, resists alcohol's disruptive effects on its protein capsid, while C. difficile spores remain viable despite sanitizer exposure, necessitating mechanical washing or sporicidal agents.^[10]^[13]^[55] The efficacy of hand sanitizers further depends on proper contact time and full coverage during application; incomplete rubbing or insufficient volume can substantially diminish antimicrobial action, with studies indicating that volumes below 2 mL result in 67% to 87% incomplete hand coverage and correspondingly reduced bacterial log reductions. Guidelines emphasize rubbing all hand surfaces until dry, typically for 20 seconds, to achieve optimal results, but deviations often lead to patchy disinfection.^[56]^[13] Compared to traditional handwashing with soap and water, sanitizers offer faster application—around 15-20 seconds versus 40 seconds for washing—but are inferior for soiled hands, food preparation, or environments with visible dirt, where mechanical friction from washing superiorly removes pathogens and debris. The Centers for Disease Control and Prevention (CDC) advises against sanitizer use in these contexts, prioritizing soap and water to ensure comprehensive germ and chemical reduction.^[1]^[10] Overuse of quaternary ammonium compounds (QACs) in alcohol-free hand sanitizers raises concerns about antimicrobial resistance, with 2020s laboratory studies demonstrating bacterial adaptations such as efflux pump upregulation and membrane modifications that confer tolerance to QACs and potential cross-resistance to antibiotics like ciprofloxacin. Clinical evidence remains limited, but increased QAC exposure during the COVID-19 pandemic has been linked to emerging tolerance in pathogens like Escherichia coli and Listeria monocytogenes, underscoring the need for judicious application to mitigate resistance risks.^[57]^[58]^[59]

Uses

Consumer and public settings

In consumer and public settings, hand sanitizers serve as a convenient option for maintaining personal hygiene when soap and water are unavailable, particularly in everyday scenarios where quick application is needed. At home, they are frequently used after meals to remove food residues or following contact with high-touch surfaces like remote controls or shopping bags, providing rapid germ reduction on clean hands.^[1] Portable formulations in small bottles, typically 1 to 2 ounces, are widely carried in purses, cars, or pockets to facilitate on-the-spot use without needing a sink.^[1] Public spaces such as retail stores, shopping malls, and airports often feature hand sanitizer dispensers at entrances, checkout areas, and high-traffic zones to encourage routine hygiene among shoppers and travelers.^[60] These installations became more prevalent following public health campaigns, including the CDC's Clean Hands Count initiative launched in the 2010s, which promoted hand hygiene awareness through posters, social media, and community outreach to reduce germ transmission in communal environments.^[61]^[62] For travel and outdoor activities, TSA-compliant hand sanitizers limited to 3.4 ounces (100 ml) per container in carry-on luggage enable passengers to sanitize hands during flights or layovers.^[63] In scenarios without washing facilities, such as hiking trails or outdoor events like festivals, compact sanitizers help prevent contamination from shared equipment or natural surfaces.^[64] Adoption trends in the 2020s have shifted toward consumer-friendly variants, with increased popularity of scented options like fruit or floral fragrances to enhance appeal and mask alcohol odor, alongside moisturizing formulas infused with vitamins such as E for skin hydration.^[65] Market growth reflects this, driven by post-pandemic preferences for multifunctional products that combine sanitation with sensory and skincare benefits.^[66]

Institutional and educational environments

In educational settings, particularly schools, hand sanitizer dispensers are commonly installed at entrances, classrooms, and high-traffic areas to promote frequent hand hygiene among students and staff. Following the 2009 H1N1 influenza pandemic, the Centers for Disease Control and Prevention (CDC) issued guidelines recommending the availability of alcohol-based hand sanitizers containing at least 60% alcohol in K-12 schools as a complement to handwashing, especially when soap and water are unavailable.^[67] These policies, updated in various state education departments such as New York's in 2020 to reflect ongoing pandemic lessons, emphasize integration into daily routines to reduce respiratory and gastrointestinal illnesses.^[68] Studies have demonstrated that such implementations can reduce infection-related absenteeism by 20-50% in elementary schools, attributing the impact to consistent use alongside education on proper application.^[69]^[70] In workplaces and offices, the Occupational Safety and Health Administration (OSHA) recommends providing alcohol-based hand sanitizers that contain at least 60% alcohol and are readily available to support hand hygiene and minimize germ transmission.^[71] These dispensers, often wall-mounted for accessibility, integrate with personal protective equipment (PPE) protocols by providing a quick alternative to handwashing during breaks or after handling communal items, as outlined in OSHA's guidance for returning to work post-pandemic.^[71] Employers are encouraged to ensure sanitizers contain at least 60% alcohol and are readily available in high-traffic zones to support overall workplace hygiene without disrupting productivity.^[72] Public facilities such as airports and shopping malls frequently deploy wall-mounted or freestanding hand sanitizer units at entry points, security checkpoints, and restrooms to facilitate hygiene for large crowds.^[73] To comply with the Americans with Disabilities Act (ADA), these dispensers must be operable with one hand, without requiring tight grasping or pinching, and positioned at heights accessible to wheelchair users, typically between 15 and 48 inches from the floor.^[74] Such designs ensure equitable access, with touchless options increasingly adopted to reduce contact points in high-volume areas like terminals and retail corridors.^[75]^[76] Despite these benefits, institutional deployment faces challenges including vandalism, which can damage units in shared spaces, necessitating vandal-resistant models for durability in high-use environments.^[77] Refilling logistics in large buildings pose additional hurdles, as manual processes risk cross-contamination and time inefficiencies for maintenance staff, prompting shifts toward automated or sealed systems to maintain supply consistency.^[78]^[79]

Healthcare and professional applications

In healthcare settings, alcohol-based hand rubs (ABHRs) are widely utilized for hand hygiene during patient care to reduce the transmission of healthcare-associated infections. These products, typically containing 60-95% ethanol or isopropanol, are recommended by the World Health Organization (WHO) as the preferred method when hands are not visibly soiled, offering rapid antimicrobial action and convenience over traditional soap-and-water washing. The WHO's "My 5 Moments for Hand Hygiene" framework guides healthcare workers to perform hand hygiene at critical points: before touching a patient, before clean/aseptic procedures, after body fluid exposure risk, after touching a patient, and after contact with patient surroundings. This approach has been adopted globally in hospitals to standardize practices and improve compliance, with studies showing it can achieve up to 50% reduction in infection rates when implemented effectively.^[11]^[13] For surgical disinfection, pre-operative hand rubs must meet stringent standards such as EN 12791, which evaluates immediate and sustained bactericidal activity through in vivo testing on human volunteers, requiring at least a 2-log10 reduction in microbial counts compared to a reference procedure. Ethanol-based formulations exceeding 75% v/v concentration are particularly effective in fulfilling these criteria, providing equivalent or superior efficacy to traditional antiseptic scrubs while minimizing skin irritation and preparation time. Foam variants of ABHRs, such as those registered under regulatory approvals like Australia's ARTG, offer no-rinse application for surgical hand preparation, ensuring even coverage and rapid drying within 120 seconds to support operating room protocols without compromising sterility.^[80]^[81] In the food industry, the FDA Food Code permits the use of FDA-approved hand antiseptics as an additional measure following proper handwashing with soap and water, particularly in processing environments to further reduce microbial contamination on employees' hands. However, hand sanitizers are not a substitute for handwashing and are restricted in scenarios involving direct contact with ready-to-eat foods, where bare-hand contact is generally prohibited unless part of a pre-approved variance procedure that includes validated controls like gloves or utensils. This framework ensures hygiene in food handling while prioritizing soap-and-water washing at designated sinks to achieve effective pathogen removal, with sanitizers applied post-wash only if they comply with food additive regulations under 21 CFR Part 178.^[82]^[83] Professional training programs in healthcare emphasize correct ABHR application techniques to maximize efficacy, often certified through resources from organizations like the CDC and WHO. These programs instruct workers to dispense sufficient product into the palm, rub hands palm-to-palm, interlace fingers, and cover all surfaces—including backs of hands, thumbs, and fingertips—for at least 20 seconds until dry, achieving comprehensive microbial reduction. Certification typically involves interactive modules and audits, such as the CDC's "Clean Hands in Healthcare" training, which integrates these techniques with the WHO's multimodal strategy to foster sustained compliance and reduce errors in high-stakes environments.^[84]^[85]

Safety and risks

Flammability hazards

Hand sanitizers containing high concentrations of alcohol, typically ethanol or isopropanol at 60% or more, present significant flammability hazards due to their classification as Class IB flammable liquids. These products can release ignitable vapors at room temperature, increasing the risk of fire when exposed to ignition sources such as sparks or open flames.^[86] The flash point of ethanol-based hand sanitizer gels ranges from 60°F to 80°F, allowing ignition under common indoor conditions if vapors accumulate. For instance, a 2013 incident at Doernbecher Children's Hospital in Portland, Oregon, involved hand sanitizer vapors ignited by static electricity, causing severe burns to a patient shortly after application. Operating room fires have also been linked to alcohol vapors from sanitizers or prep solutions near electrocautery devices, underscoring the need for caution in medical settings.^[87]^[88]^[89] Proper storage follows the National Fire Protection Association (NFPA) 30 Flammable and Combustible Liquids Code, which requires limiting quantities in enclosed spaces—such as no more than 5 gallons per smoke compartment without additional protections—to avoid vapor buildup, and mandates separation from heat sources like electrical equipment or sunlight. Storage cabinets must be approved for flammables, with spill containment to prevent pooling that could spread fires.^[90] Use precautions include applying sanitizer in well-ventilated areas away from ignition sources and allowing it to dry fully before proximity to flames, as recommended by the U.S. Food and Drug Administration (FDA). To prevent accidental misuse, such as children using sanitizer as a fuel substitute for play or lighters, secure storage with child-resistant caps is advised, aligning with general consumer product safety guidelines.^[3]^[91] In high-risk environments like hospitals or laboratories, mitigation strategies involve switching to low-alcohol formulations (below 60%) or non-flammable alternatives, such as those based on benzalkonium chloride, which maintain efficacy without the fire risk.^[92]

Skin and dermal effects

Hand sanitizers, particularly alcohol-based formulations (ABHS), induce acute skin dryness by solubilizing and removing components of the intercellular lipids in the stratum corneum, disrupting the skin's natural barrier function.^[31] This lipid depletion leads to transepidermal water loss and irritant contact dermatitis, characterized by redness, itching, and scaling. Studies report that frequent users, such as healthcare workers applying ABHS more than 10 times daily, experience adverse skin reactions in 21% to 55% of cases, with higher rates during periods of intensive hygiene like the COVID-19 pandemic.^[93] Chronic use exacerbates these effects, resulting in skin cracking, fissuring, and exacerbation of underlying conditions like eczema. Prolonged exposure to alcohol can worsen atopic dermatitis by further compromising the skin barrier, leading to increased permeability and inflammation. Additionally, 2020s research highlights that repeated antimicrobial application disrupts the skin microbiome, reducing microbial diversity and potentially contributing to dysbiosis-linked dermatological issues, such as heightened susceptibility to infections or allergic responses.^[94] For instance, surveys during the pandemic found cracked skin in up to 33% of regular users. Post-pandemic studies (as of 2024) suggest potential for persistent skin microbiome dysbiosis in frequent users, increasing long-term infection susceptibility, though recovery occurs with reduced use.^[95]^[96] To mitigate these dermal effects, ABHS formulations often incorporate humectants like glycerol, which acts as an emollient to retain moisture and reduce dryness, as recommended in World Health Organization guidelines. Hypoallergenic variants minimize irritants such as fragrances, while rotating hygiene methods—using soap and water when feasible—helps prevent cumulative damage by avoiding constant alcohol exposure. Vulnerable populations, including children with thinner skin barriers, the elderly with age-related dryness, and individuals with atopic dermatitis, exhibit heightened sensitivity, experiencing amplified irritation and barrier disruption at lower usage frequencies.^[97]^[98]

Ingestion and toxicity

Ingestion of hand sanitizers, which typically contain high concentrations of ethanol or isopropanol, can result in acute alcohol poisoning, leading to symptoms such as nausea, vomiting, abdominal pain, central nervous system depression, and in severe cases, coma, seizures, respiratory depression, and organ damage.^[99]^[100] Children are particularly vulnerable due to their smaller body size and immature liver enzymes, which can cause rapid intoxication and hypoglycemia from even small amounts, as low as 10-30 mL of product containing 60% alcohol.^[99]^[101] The lethal dose (LD50) for ethanol is approximately 5-8 g/kg in adults and 3 g/kg in children, while for isopropanol it is around 5 g/kg based on animal data extrapolated to humans, though human fatalities have occurred with ingestions as low as 200 mL of 70% solution.^[100] Prior to 2020, U.S. poison control centers reported nearly 85,000 exposures to hand sanitizers among children from 2011 to 2015, averaging over 17,000 cases annually, with most involving unintentional ingestion and resulting in minor effects like vomiting, though rare severe outcomes included coma and hypoglycemia.^[10] Chronic risks from repeated ingestion are less documented but may include long-term neurological effects from sustained alcohol exposure, particularly in cases of intentional misuse.^[102] To deter ingestion, hand sanitizers often include denaturants such as denatonium benzoate (commonly known as Bitrex), a bittering agent added at concentrations of 20-50 ppm to make the product unpalatable.^[103] However, cases of methanol contamination in illicit or substandard products have led to severe toxicity, including metabolic acidosis, blindness, and death; for instance, in 2020, the FDA identified over 100 contaminated products, with 15 reported poisonings in Arizona and New Mexico resulting in four fatalities. As of 2025, the FDA continues to issue warnings and recalls for methanol-contaminated products, with recent alerts noting adverse events including deaths from ingestion; additionally, 2025 recalls of certain sanitizers due to bacterial contamination (e.g., Burkholderia cepacia) increase infection risks for immunocompromised users.^[45]^[104]^[105] In response to ingestion, poison control protocols recommend immediate contact with a poison center (e.g., via 1-800-222-1222 in the U.S.) for guidance, which may include monitoring for symptoms, administering activated charcoal if recent, supportive care like IV fluids and glucose for hypoglycemia, and in severe cases, hemodialysis for methanol or high alcohol levels.^[106] Following the COVID-19 pandemic surge in household stockpiling, health authorities in the 2020s issued warnings emphasizing secure storage to prevent child access, noting that even a lick of sanitizer can cause poisoning in toddlers.^[3]^[103]

Systemic absorption concerns

Hand sanitizers, particularly alcohol-based formulations, can lead to systemic absorption of active ingredients through both dermal penetration and inhalation of vapors, raising concerns about potential internal health effects. Pharmacokinetic studies on ethanol-based products have demonstrated that 0.5% to 2.3% of the applied alcohol is absorbed into the bloodstream during hygienic or surgical hand disinfection, depending on the alcohol concentration (55% to 95%) and application volume.^[107] Peak blood ethanol concentrations typically occur within 20 to 30 minutes post-application, reaching levels of 6.9 to 30.1 mg/L after excessive use simulating multiple applications, though these remain below toxic thresholds for adults.^[107] Inhalation contributes significantly in enclosed environments, with vapor exposure during surgical disinfection yielding absorbed doses up to 203.9 mg per procedure, equivalent to short bursts exceeding short-term exposure limits (9.5 mg/L) for up to 63 seconds.^[108] In surgical contexts, where hand sanitizers are used for preoperative preparation, absorption risks extend to non-alcohol agents like chlorhexidine, which can trigger rare but severe anaphylactic reactions due to systemic uptake, particularly via mucosal surfaces. Chlorhexidine-related anaphylaxis accounts for 7.7% to 9.6% of perioperative anaphylaxis cases, with incidence rates below 1% overall but increasing in procedures involving urologic or gynecologic exposure.^[109] Alcohol vapors from sanitizers in operating rooms further amplify inhalation risks, potentially leading to transient elevations in blood alcohol levels among staff and patients, though no direct links to acute surgical complications have been established beyond general ventilation recommendations.^[108] Vulnerable populations, such as premature infants, face heightened absorption due to thinner skin and immature barriers, allowing evaporated alcohol from nearby sanitizer use to penetrate via dermal and respiratory routes. In neonatal intensive care units, blood alcohol concentrations in preterm infants (<34 weeks gestation) reached medians of 7.0 mg/dL from ambient vapors before interventions reduced exposure, highlighting the need for modified application practices in incubators.^[110] For healthcare workers with chronic exposure, repeated applications (e.g., 20+ times daily) result in detectable systemic ethanol, but long-term effects like liver enzyme alterations remain understudied, with isolated case reports suggesting potential hepatic impacts from isopropanol variants rather than routine ethanol use.^[111] Monitoring systemic absorption involves measuring blood alcohol levels following heavy sanitizer use, particularly in high-risk settings, with peaks detectable via gas chromatography for up to several hours. Guidelines from health authorities, such as those for neonatal care, recommend limiting application frequency and delaying hand entry into enclosed spaces to minimize vapor accumulation, though no universal caps exist for adult occupational use due to low overall toxicity.^[110]^[107]

Production and regulation

Manufacturing processes

Hand sanitizer manufacturing begins with sourcing high-purity raw materials to ensure efficacy and safety. Ethanol, the primary active ingredient, is typically obtained through fermentation and distillation processes from agricultural feedstocks like corn or sugarcane, or via synthetic methods from petrochemicals, and must meet pharmaceutical-grade standards such as USP or equivalent for purity, with limits on impurities like methanol (≤630 ppm) and benzene (≤2 ppm).^[112] Isopropyl alcohol serves as an alternative, sourced similarly and verified for 99.8% purity. Other components include distilled or boiled water, humectants like glycerol (98% purity), and hydrogen peroxide (3-6% solution) for microbial spore elimination, all procured from certified suppliers to prevent contamination.^[17] The mixing phase employs batch processes in stainless steel or plastic vessels under sanitary conditions to blend ingredients precisely. For alcohol-based formulations, ethanol or isopropyl alcohol (75-96% v/v) is combined with water, glycerol (1.45% v/v), and hydrogen peroxide (0.125% v/v), often using high-shear mixers to achieve homogeneity without aeration, which could introduce bubbles and affect stability.^[28] pH is adjusted to 5-7 using neutralizers like triethanolamine for optimal viscosity and skin compatibility, particularly in gel formulations. Contamination is avoided through dedicated equipment, filtered air environments, and sequential addition of ingredients—starting with water and humectants before alcohol—to minimize volatile loss and ensure uniform distribution.^[17]^[28] Production of specific forms follows mixing, tailored to gel, liquid, or foam variants. For gels, carbomers (0.2-1% w/w, such as Carbopol®) are dispersed into the aqueous phase under high shear to form a lump-free suspension, then neutralized to activate gelling and achieve a clear, viscous product suitable for pump bottles. Foaming formulations incorporate surfactants (e.g., 0.5-2% sodium lauryl sulfate or non-ionic types) to lower viscosity and enable foam generation upon dispensing, without altering the base mixing process significantly. The mixture is then filled into polyethylene terephthalate (PET) or high-density polyethylene (HDPE) bottles (100-1000 ml capacities) using automated filling lines to prevent exposure to air and maintain sterility.^[28]^[113] Quality assurance encompasses rigorous testing throughout and post-production to verify product integrity. Microbial testing, per pharmacopeial standards like the European Pharmacopeia, checks for bacterial, yeast, and mold contamination after a 72-hour quarantine period, during which hydrogen peroxide eliminates spores. Stability trials assess shelf life (typically 2-3 years) through accelerated aging tests monitoring alcohol concentration (via alcoholmeter or gas chromatography), pH, viscosity, and efficacy against microbes, ensuring no degradation under controlled storage conditions. Scale-up from laboratory to industrial production involves validating larger batch sizes (e.g., 50-10,000 L) with pilot runs to confirm consistency in mixing dynamics and final product uniformity.^[17]^[114]^[44]

Regulatory standards and guidelines

In the United States, the Food and Drug Administration (FDA) regulates hand sanitizers as over-the-counter (OTC) drug products under the Topical Antiseptic Drug Products for Over-the-Counter Human Use monograph, requiring alcohol-based formulations to contain at least 60% ethyl alcohol or 70% isopropyl alcohol by volume to ensure efficacy against microorganisms.^[115]^[116] The FDA enforces these standards through actions against non-compliant products, including widespread recalls in 2020 of hand sanitizers contaminated with methanol, a toxic substance not permitted in these products, resulting in over 200 advisories and warning letters to manufacturers for adulterated or misbranded items.^[45]^[117] In the European Union and United Kingdom, hand sanitizers are classified as biocidal products under the Biocidal Products Regulation (BPR) (EU) No. 528/2012, which mandates authorization for active substances and compliance with efficacy standards such as EN 1500 for hygienic hand disinfection and EN 12791 for surgical hand disinfection to verify bactericidal and virucidal activity.^[118]^[119] Products must also meet general safety requirements, with CE marking required if classified as medical devices (e.g., dispensers), though most alcohol-based sanitizers fall under BPR rather than the Medical Devices Regulation.^[120]^[119] The World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) provide global guidelines recommending alcohol-based hand sanitizers with a minimum of 60% alcohol concentration for effective reduction of transient microorganisms, aligning with standards for broad-spectrum antimicrobial activity. Recent WHO guidelines (2024) stress integrated hygiene to address antimicrobial resistance from sanitizer overuse, while FDA encourages sustainable ethanol sourcing as of 2025.^[17]^[10]^[121]^[122] In 2016, the FDA banned triclosan and 18 other antimicrobial agents in consumer antiseptic washes (such as hand soaps), due to insufficient evidence of safety and efficacy over plain soap and water, a decision echoed in WHO and CDC recommendations against non-alcohol active ingredients in such products.^[123]^[1] Regulatory standards vary internationally, with some countries enforcing stricter minimum alcohol thresholds (e.g., 70% in certain regions) or less rigorous testing, leading to circulation of subpotent products that fail to meet WHO efficacy benchmarks and pose public health risks.^[124]^[24] As of late 2025, the EU's ECHA is considering proposals under the BPR to classify ethanol in biocidal products as reprotoxic (Category 1A), which could lead to enhanced hazard labeling or restrictions if approved, while sustainability initiatives emphasize eco-friendly packaging and reduced environmental impact in product formulations.^[125]^[126]^[127]

Pandemic influences and developments

The COVID-19 pandemic caused an unprecedented surge in demand for hand sanitizers worldwide, resulting in widespread shortages by early 2020 as consumers and institutions stockpiled supplies to mitigate viral transmission. In the United States, hand sanitizer sales increased by approximately 600% that year, far outpacing regular production capacity and prompting emergency measures to bolster output.^[128]^[129]^[130] Numerous distilleries converted their facilities to produce ethanol-based sanitizers, leveraging existing alcohol distillation infrastructure to supply healthcare providers and frontline workers; for example, nearly 40 craft distilleries in New York State alone shifted production with technical guidance to meet regional needs.^[131]^[132]^[133] Supply chain challenges exacerbated the crisis, with global ethanol shortages in 2020 disrupting sanitizer manufacturing due to redirected supplies for medical and fuel uses amid pandemic-related logistics strains. These issues were largely resolved by 2021, as regulatory agencies provided temporary flexibilities for technical-grade ethanol and production pathways stabilized with increased sourcing. Concurrently, authorities intensified crackdowns on counterfeit products; the U.S. Food and Drug Administration issued multiple alerts in 2020 about toxic batches contaminated with methanol, leading to import bans on certain foreign sanitizers and over 100 product recalls to prevent poisoning risks.^[134]^[135]^[136] The World Health Organization also highlighted substandard and falsified sanitizers in global alerts, emphasizing quality control to safeguard public health during peak demand.^[45]^[117]^[137] Pandemic pressures spurred innovations in hand sanitizer formulations, including long-lasting variants designed for extended protection. Products such as non-alcohol-based foaming sanitizers have claimed up to 24-hour germ-killing efficacy, often incorporating agents like quaternary ammonium compounds or silver ions. Eco-friendly developments gained traction post-2020, with biodegradable gels formulated from plant-derived alcohols and natural thickeners emerging to address environmental concerns from single-use plastics and chemical runoff.^[138]^[139] From 2023 to 2025, the hand sanitizer market normalized after the acute crisis, with global sales stabilizing at a projected compound annual growth rate of around 6%, driven by sustained hygiene awareness rather than emergency stockpiling. Industry focus shifted toward sustainability, incorporating biodegradable ingredients, recyclable packaging, and ethical sourcing to align with consumer preferences for low-impact products. Emerging studies during this period examined the pandemic-era overuse of sanitizers, linking frequent application to potential contributions in antimicrobial resistance among bacteria, and recommended integrated hygiene strategies to mitigate long-term public health risks.^[65]^[140]^[141]^[142]^[143]^[144]

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None
Below is a merged summary of hand sanitizer and handwashing content from the FDA Food Code 2022 (Chapters 2 and 3, and Annexes 2, 3, 4, 5, and 7) based on the provided segments. To retain all information in a dense and organized manner, I will use a combination of narrative text and a table in CSV format for detailed section-specific data. The narrative will provide an overview, while the table will capture specific sections, requirements, and mentions of hand sanitizers or handwashing across the chapters and annexes.
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Ethanol toxicity results from the ingestion of large amounts of ethanol, usually in the form of alcohol. It affects multiple organ systems in both the acute and ...
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Hand Sanitizers: Keep Children Safe from Poisoning Risk
Oct 22, 2021 · You can check for bitter ingredients such as denatonium benzoate (Bitrex); sucrose octaacetate; or butanol (also called tert-butyl alcohol).
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Aug 14, 2020 · Alcohol-based hand sanitizer products should never be ingested. In patients with compatible signs and symptoms or after having swallowed hand ...
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[PDF] Alcohol Requirements for Hand Sanitizer Production
Jan 27, 2021 · However, FDA laboratory testing of batches of this product detained at the border found that the product contained 0% ethanol and 83% methanol v ...
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How to make hand sanitiser gel - PMC - NIH
Use a mixer or homogeniser to hasten the process (Figure 1b and 1c). Add the measured alcohol into the mixing container (Figure 1d).
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FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from ...
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[PDF] Guidance on the applicable legislation for leave-on hand cleaners ...
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Aug 6, 2025 · The point of this article is to help in understanding the administrative prerequisites expected to bring the hand sanitizers or sanitizer items ...
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Cornell aids distillers in making hand sanitizer
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Distilleries are making hand sanitizer with their in-house alcohol and ...
Mar 19, 2020 · Distilleries are stepping in to help combat the hand sanitizer shortage by using the alcohol in their facilities to create their own alcohol-based solutions.
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Hand sanitizer products have recently been indicated in methanol poisonings causing blindness in 2 New Mexicans and death in 7.
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Development and efficacy assessment of hand sanitizers and ...
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Hand Sanitizer Market Size & Trends 2025-2035
Hand sanitizer market to grow from USD 5.8 billion in 2025 to USD 10.3 billion by 2035 at 5.9% CAGR, driven by hygiene awareness and infection prevention.
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Global Hand Sanitizer Market: Impact of Environmental, Social, and ...
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Commercial Hand Sanitizers use amid COVID-19 Pandemic
Sep 14, 2025 · The growing menace of antimicrobial resistance is unfortunately further exacerbated by the misuse and overuse of disinfectants such as ...