Isopropyl alcohol

Approved Medical Uses:

A. Topical Antiseptic:

• For disinfecting intact skin before injections, venipuncture, or minor surgical procedures.
• Used in preoperative skin preparation in clinical settings.

B. Hand Sanitizer Active Ingredient:

• Primary agent in alcohol-based hand rubs (ABHRs) for reducing microbial flora on hands.
• Effective against bacteria, fungi, and many enveloped viruses including influenza and SARS-CoV-2.

C. First Aid Antiseptic:

• Applied to minor cuts, scrapes, and burns to prevent infection.

D. Surface Disinfectant (Medical and Domestic):

• Approved for disinfecting hard non-porous surfaces in healthcare and household settings.
• Used in hospitals, laboratories, and clean rooms.

Off-Label / Practically Accepted Uses:

• Disinfection of electronic equipment (e.g., mobile phones, keyboards).
• Emergency sterilization of instruments when no alternatives are available.

Route of Administration:

• Topical only. Not for oral, intravenous, or ophthalmic use.

Adults & Elderly:

• Skin Antiseptic: Apply directly to clean, dry skin using gauze or cotton ball; allow to dry before procedure.
• Hand Sanitization (in solutions 60–90% v/v): Apply 2–3 mL to palms; rub thoroughly over hands for 20–30 seconds until dry.

Pediatrics:

• Safe when used externally under adult supervision.
• Avoid in neonates and infants under 2 months due to increased skin absorption risk.

Special Populations (Renal/Hepatic Impairment):

• No dosage adjustment required for topical use.
• Avoid application on broken or inflamed skin to prevent systemic absorption.

Frequency:

• As required for disinfection or per clinical hygiene protocol.

Duration:

• Single-use or repeated use depending on setting and indication.

Important Administration Notes:

• Do not apply to mucous membranes or open wounds.
• Allow area to air dry fully before exposure to heat or medical devices (e.g., electrocautery).
• Use in well-ventilated area to minimize inhalation risk.

Isopropyl alcohol exerts its antimicrobial effects primarily by denaturing proteins and disrupting microbial cell membranes. When applied to the skin or surfaces, it penetrates the lipid bilayer of bacterial or viral envelopes and causes coagulation of intracellular proteins. This leads to rapid cell lysis and microbial death. The alcohol content (typically 70% for optimal activity) evaporates quickly, making it suitable for fast-acting antiseptic use without leaving residue. Isopropyl alcohol is effective against a broad spectrum of microorganisms, including Gram-positive and Gram-negative bacteria, enveloped viruses, and some fungi.

Absorption:

• Minimally absorbed through intact skin.
• Increased absorption through damaged skin or with prolonged exposure.

Distribution:

• Systemic distribution is minimal with proper topical use.
• If absorbed, it is widely distributed in body fluids and tissues.

Metabolism:

• Metabolized primarily in the liver via alcohol dehydrogenase to acetone.

Excretion:

• Excreted through urine (as acetone or unchanged) and lungs (exhaled).

Onset of Action:

• Rapid onset; kills most microbes within 15–30 seconds of contact.

Half-life (if systemically absorbed):

• Approximately 2.5 to 8 hours, depending on dose and route of exposure.

Bioavailability:

• Not applicable for topical use. Systemic bioavailability is negligible unless ingested or applied excessively on compromised skin.

Pregnancy:

• Not assigned a specific FDA pregnancy category for topical use.
• Safe when applied externally in small quantities.
• Avoid excessive or prolonged exposure, particularly on damaged skin, due to possible systemic absorption.

Lactation:

• Minimal systemic absorption through skin makes excretion into breast milk unlikely.
• Safe for use during breastfeeding.
• Avoid application near the nipple area to prevent infant exposure.

Precaution:

• Limited clinical data in pregnant or lactating women; use caution, especially in high-frequency healthcare settings.

• Primary Class: Topical Antiseptic / Disinfectant
• Subcategory: Alcohol-Based Antimicrobial Agent

• Known hypersensitivity to isopropyl alcohol or any product components.
• Application to open wounds or mucosal membranes.
• Ingestion or inhalation (toxic and potentially fatal).
• Use near heat sources, sparks, or open flames (highly flammable).
• Use in infants under 2 months of age.

• Flammable Warning: Extremely flammable; keep away from fire, flame, or heat sources until completely dry.
• Eye Irritation: May cause severe eye irritation; flush with water immediately if accidental contact occurs.
• Systemic Toxicity: Prolonged use on damaged skin may lead to systemic absorption and toxicity (e.g., CNS depression, hypotension).
• Inhalation Risk: Avoid excessive vapor exposure, especially in poorly ventilated areas.
• Pediatric Use: Avoid use in premature infants or neonates due to skin permeability and risk of toxicity.

Clinical Monitoring (If Overexposed):

• Signs of alcohol toxicity: dizziness, confusion, vomiting, hypotension, respiratory depression.

Common Side Effects:

• Dermatologic: Dry skin, redness, stinging, peeling, or irritation with frequent use.

Less Common:

• Contact dermatitis (especially with repetitive application).
• Allergic skin reactions (rash, hives, itching).

Serious or Rare:

• Systemic alcohol toxicity (if ingested or overused on broken skin).
• Eye injury from accidental contact.
• Central nervous system depression with inhalation or ingestion.

Severity: Generally mild and transient with proper use.
Onset: Immediate or within minutes of application.
Dose-Dependence: Severity increases with frequency, volume, or improper use.

Drug-Drug Interactions (Topical Use):

• Not significant for external application.

Chemical Incompatibilities:

• Avoid concurrent topical use with oxidizing agents (e.g., hydrogen peroxide) unless in a stabilized formulation.
• Do not mix with bleach, acids, or alkalis due to risk of toxic gas formation.

Alcohol Interaction:

• May potentiate CNS depressant effects if inhaled or ingested with other alcohols or sedatives.

Enzyme System:

• Alcohol dehydrogenase involved in metabolism (only relevant for systemic exposure).

• WHO and CDC Guidelines:
• Isopropyl alcohol (60–90%) remains a key component of hand sanitizers and disinfection protocols during pandemics (e.g., COVID-19).
• WHO-recommended hand rub includes 75% isopropyl alcohol with glycerol and hydrogen peroxide.
• Updated Safety Labeling:
• Emphasis on flammability warnings and supervision requirements in household and medical settings.
• Increased regulations on packaging to prevent accidental ingestion, particularly by children.
• FDA Consumer Alerts:
• Public safety advisories issued regarding ingestion and inappropriate use of alcohol-based sanitizers containing isopropyl alcohol.

• Temperature: Store at 15°C to 30°C (59°F to 86°F).
• Humidity: Keep in a dry place with tight cap closure.
• Light Protection: Store away from direct sunlight.
• Handling Instructions:
• Store in a cool, well-ventilated area.
• Keep container tightly closed.
• Use with care—extremely flammable.
• Keep out of reach of children.
• Do Not Freeze.