HandiSanitizer

Approved and Clinically Accepted Uses:

A. Antiseptic and Disinfectant Uses:

• Hand Antisepsis: For hygienic hand disinfection in medical, domestic, or public settings to reduce the transmission of bacteria and viruses.
• Skin Antiseptic (Pre-Injection/Pre-Surgical): Used before injections, blood draws, and minor surgical procedures on intact skin.
• First Aid Antiseptic: For cleaning minor cuts, abrasions, and superficial burns to prevent infection.

B. Surface and Equipment Disinfection:

• Disinfection of non-porous surfaces including metal, plastic, and glass in healthcare facilities and laboratories.
• Accepted off-label use for cleaning electronic devices (e.g., phones, keyboards) due to rapid evaporation and broad-spectrum antimicrobial activity.

C. Public Health Applications:

• Widely recommended in emergency outbreak scenarios (e.g., COVID-19 pandemic) for hand rub formulations where soap and water are not available.
• Part of the WHO-recommended alcohol-based hand rub formulation for infection prevention and control.

Route of Administration:

• Topical (external use only)

Adult and Elderly:

• Hand Disinfection: Apply 2–3 mL of solution to the palm; rub thoroughly over all hand surfaces for 20–30 seconds until completely dry.
• Skin Antiseptic: Apply a small amount to the target area using a sterile swab or gauze; allow to air dry before procedure.

Pediatrics:

• Use with caution under adult supervision; avoid use in children under 2 months of age due to risk of percutaneous absorption and skin irritation.

Special Populations:

• Renal or Hepatic Impairment: No dose adjustment necessary when used topically; however, avoid excessive or prolonged application on broken skin.

Frequency:

• As needed or according to clinical hygiene protocols. Repeated use may cause skin dryness.

Important Instructions:

• Do not apply on open wounds, mucous membranes, or near eyes.
• Do not use internally or inhale fumes.
• Keep away from flames and heat sources due to flammable nature.

Isopropyl Alcohol acts primarily by denaturing proteins and disrupting cell membranes, leading to rapid cell lysis and death of bacteria, fungi, and enveloped viruses. Hydrogen Peroxide works as an oxidizing agent, generating reactive oxygen species (ROS) that damage essential cellular components such as lipids, proteins, and DNA. This enhances its broad-spectrum antimicrobial efficacy, particularly against anaerobic organisms. Glycerol functions as a humectant, preventing skin dehydration by retaining moisture; it does not contribute to antimicrobial activity but improves tolerability for frequent use. Together, the combination ensures rapid, effective, and skin-friendly disinfection.

Absorption:

• Isopropyl Alcohol: Absorbed minimally through intact skin; absorption increases significantly with repeated application or compromised skin integrity.
• Hydrogen Peroxide: Poor transdermal absorption; rapidly broken down by catalase enzymes.
• Glycerol: Topical absorption is negligible; acts locally on the skin.

Distribution:

• Limited systemic distribution under normal use; systemic exposure only in cases of ingestion or use on damaged skin.

Metabolism:

• Isopropyl Alcohol: Hepatically metabolized to acetone via alcohol dehydrogenase.
• Hydrogen Peroxide: Rapidly decomposed into water and oxygen.
• Glycerol: If absorbed, metabolized primarily in the liver to glucose or excreted unchanged.

Elimination:

• Isopropyl Alcohol: Excreted via urine and lungs.
• Hydrogen Peroxide: Broken down in tissues; no renal excretion.
• Glycerol: Renal excretion of unchanged compound or metabolites.

Half-life:

• Not applicable for standard topical use; systemic exposure is minimal.

Pregnancy:

• No specific FDA category assigned.
• Considered safe for external use during pregnancy when used as directed.
• Avoid frequent application on damaged skin to minimize systemic absorption.

Lactation:

• Safe for external use during breastfeeding.
• Do not apply to the breast or nipple area to avoid infant ingestion.
• No evidence of excretion into breast milk when used topically.

Note:
Caution is advised due to lack of extensive controlled studies in pregnant or lactating women, but minimal risk is expected with proper external use.

• Primary Class: Antiseptic / Disinfectant
• Pharmaceutical Category: Alcohol-Based Topical Antiseptic with Oxidizing Agent and Emollient

• Known hypersensitivity or allergic reaction to isopropyl alcohol, hydrogen peroxide, or glycerol.
• Application to open wounds, eyes, or mucous membranes.
• Ingestion or inhalation (toxic and potentially fatal).
• Use in neonates under 2 months (due to skin absorption and irritation risk).
• Flammable product: contraindicated near open flames or heat-producing medical devices (e.g., electrocautery) until fully dried.

• Flammable: Keep away from heat sources, sparks, open flames, and hot surfaces.
• Eye Contact Hazard: May cause serious eye irritation; flush with water immediately if contact occurs.
• Skin Sensitivity: Prolonged or repeated use may cause dryness, irritation, or dermatitis.
• Systemic Toxicity Risk: Avoid excessive use on broken or inflamed skin due to potential for systemic absorption.
• Ingestion Hazard: Ingesting isopropyl alcohol is toxic and may result in nausea, vomiting, CNS depression, respiratory issues, or death.
• Ventilation Required: Ensure adequate ventilation during use to avoid inhaling vapors.

Common Side Effects (Dermatologic):

• Dryness
• Mild irritation or redness
• Transient stinging sensation

Less Common:

• Cracked or peeling skin
• Contact dermatitis with frequent use

Rare/Serious:

• Allergic skin reactions (rash, swelling, itching)
• Eye damage from accidental contact
• Systemic toxicity (only if ingested or used improperly on damaged skin)

Onset: Immediate to within 30 minutes of use
Severity: Generally mild and reversible with discontinuation

Topical Use:

• No significant systemic drug-drug interactions under normal external use.

Chemical Interactions:

• Avoid co-use with iodine-based antiseptics, chlorhexidine, or other oxidizing agents on the same site to prevent chemical instability or reduced efficacy.
• Do not mix with bleach or strong acids due to risk of hazardous gas formation.

CYP450 Interactions:

• Not applicable due to minimal systemic absorption.

• WHO-Recommended Hand Rub Formulation: WHO endorses the use of:
• Isopropyl Alcohol (75% v/v),
• Hydrogen Peroxide (0.125% v/v),
• Glycerol (1.45% v/v),
• Purified Water (quantity sufficient to 100%),
  especially in low-resource or emergency settings.
• COVID-19 Guidelines: Global health authorities reinforced the use of alcohol-based hand rubs (containing at least 60% alcohol) with hydrogen peroxide and glycerol for effective control of enveloped viruses including SARS-CoV-2.
• Labeling Compliance: Regulatory bodies now require explicit labeling for flammability, toxicity, and external use only.

• Temperature: Store at 15°C to 30°C (59°F to 86°F).
• Humidity: Keep in a dry area; tightly close container after each use.
• Light Protection: Store away from direct sunlight.
• Handling Precautions:
• Highly flammable: Do not store near flames or heat.
• Use in well-ventilated environments.
• Do not freeze or refrigerate.
• Packaging: Store in clearly labeled, original containers with child-resistant caps.