HandiSafe

Approved Indications:

• Skin Antisepsis:
  For pre-injection skin preparation and minor skin disinfection prior to invasive procedures.
• Wound Cleaning:
  Used for cleansing minor cuts, abrasions, and superficial wounds to reduce microbial contamination.
• Hand Disinfection:
  Suitable for antiseptic hand rubs in healthcare settings or personal hygiene.
• Disinfection of Minor Skin Infections:
  Adjunct treatment for preventing infection in minor superficial skin trauma.

Off-label / Clinically Accepted Uses:

• Surface Disinfection:
  Used for disinfecting small instruments or surfaces where mild antiseptic action is needed.
• Oral Mucosa Cleaning (Diluted Use):
  Occasionally diluted and used as a mouth rinse for oral hygiene (caution advised).

Formulation & Concentrations:

• Ethyl Alcohol: Typically 60–70% v/v concentration (effective antiseptic range).
• Hydrogen Peroxide: Approximately 0.5–3% w/v concentration.
• Glycerol: Added as a humectant/moisturizer, concentration varies (1–5%).

Route of Administration: Topical (external use only)

Administration Instructions:

• Apply directly to the skin area needing disinfection or cleaning.
• Use a sterile cotton swab, gauze, or spray as appropriate.
• Allow to dry naturally; do not rinse off.
• Frequency depends on clinical need; typically applied once or twice before procedures.

Special Populations:

• Pediatrics: Use with caution; avoid application on large areas of broken skin or mucous membranes.
• Elderly: No specific dose adjustments, but skin fragility requires gentle application.
• Renal/Hepatic Impairment: No systemic absorption expected; no dosage adjustment necessary.

Ethyl Alcohol exerts its antimicrobial effect by denaturing proteins and dissolving lipids, causing rapid cell membrane disruption and cell death of bacteria, fungi, and many viruses. Hydrogen Peroxide acts as an oxidizing agent, releasing free oxygen radicals that damage microbial cell components, leading to broad-spectrum microbicidal activity, including spores. Glycerol serves primarily as a moisturizing agent that helps prevent skin dryness caused by alcohol and peroxide, maintaining skin integrity during repeated application.

• Absorption: Minimal systemic absorption through intact skin; negligible bioavailability.
• Distribution: Not applicable due to topical use.
• Metabolism: Ethyl alcohol and hydrogen peroxide are metabolized rapidly if absorbed, but systemic exposure is minimal.
• Elimination: Primarily local action; excess hydrogen peroxide decomposes into water and oxygen.
• Onset: Immediate antimicrobial effect upon contact.
• Duration: Effect lasts until evaporation or removal.

• Pregnancy:
  Safe for topical use during pregnancy. No systemic effects anticipated with proper external use.
• Lactation:
  No known risks during breastfeeding. Topical use on skin does not affect breast milk.

• Primary Class: Topical Antiseptic and Disinfectant
• Subclass: Alcohol-based antiseptic with oxidizing agent and moisturizing additive.

• Known hypersensitivity or allergy to ethyl alcohol, hydrogen peroxide, glycerol, or formulation excipients.
• Application to large areas of deep or puncture wounds, severe burns, or mucous membranes without dilution.
• Use on eyes or ear canal.
• Avoid use in patients with a history of contact dermatitis from alcohol or peroxide.

• Flammability: Highly flammable due to ethyl alcohol content; keep away from flames and heat.
• Skin Irritation: May cause dryness, irritation, or allergic contact dermatitis, especially with repeated use.
• Hydrogen Peroxide: May cause tissue irritation or damage if used excessively or on deep wounds.
• Avoid ingestion: Toxic if swallowed.
• Not for internal use or application on large open wounds.
• Use in Children: Avoid extensive or frequent use in infants due to skin sensitivity.
• Eye Contact: Rinse immediately with water and seek medical attention.

Common Adverse Effects:

• Local skin irritation
• Dryness and peeling
• Burning or stinging sensation on application

Rare/Serious Side Effects:

• Allergic contact dermatitis
• Chemical burns (especially with hydrogen peroxide overuse)
• Hypersensitivity reactions

• No significant systemic drug interactions due to topical use.
• Caution with concurrent use of other skin irritants or sensitizers to avoid additive irritation.
• Avoid mixing with strong oxidizing agents or other antiseptics on the same skin area without medical advice.

• WHO and CDC continue to recommend alcohol-based antiseptics with ≥60% ethanol concentration as effective agents for hand hygiene and skin disinfection.
• Recent guidelines emphasize addition of glycerol or humectants to reduce skin dryness during frequent hand antisepsis.
• No new contraindications or safety warnings have been added recently.
• Emphasis on avoiding hydrogen peroxide use on deep wounds due to potential cytotoxicity.

• Store at 20°C to 25°C (68°F to 77°F).
• Keep container tightly closed in a well-ventilated, dry place.
• Protect from heat, sparks, open flames, and direct sunlight.
• Avoid freezing; store away from children and pets.
• Do not store near oxidizable materials or strong acids.