Ethanol + Isopropyl alcohol

Approved Medical Uses:

• Topical antiseptic: For pre-injection skin cleansing and minor wound disinfection.
• Surgical site preparation: Used before surgery to reduce microbial load on skin.
• Hand hygiene: As a main active component in alcohol-based hand sanitizers (ABHS).
• Surface disinfection: Used in medical settings to disinfect surfaces and equipment.

Clinically Accepted Off-Label Uses:

• Solvent in pharmaceutical compounding: Used as a carrier for certain topical or oral formulations.
• Evaporative cooling agent (rubbing alcohol): Occasionally used in fever management, though not recommended in children due to systemic absorption risk.
• Foot sanitization in diabetic care: For prevention of infections in high-risk patients.

Topical Use – Adults and Children ≥2 Years:

• Pre-injection skin prep: Apply with sterile cotton/gauze; allow to dry.
• Hand sanitizing: Apply 3–5 mL (approximately one palmful) and rub hands for 20–30 seconds until dry.
• Surgical site prep: Clean area thoroughly; allow to air dry completely before incision.

Disinfection of Surfaces/Objects:

• Apply 70–90% solution directly and wipe or allow to air dry. Avoid use on sensitive electronic equipment unless specified.

Pediatric Use (<2 years):

• Use only under strict medical supervision. Avoid application to large or damaged skin surfaces due to increased risk of systemic toxicity.

Special Populations:

• Renal/Hepatic Impairment: No dosage adjustment needed for topical use.
• Elderly: Safe if applied to intact skin; monitor for skin dryness or irritation.

Route of Administration:

• Topical only
• Not for oral, ophthalmic, vaginal, rectal, or intravenous use

Ethanol and isopropyl alcohol exert their antimicrobial action primarily by denaturing microbial proteins and disrupting lipid membranes. This leads to irreversible damage to the cell wall and cytoplasmic content leakage, causing rapid cell death. They are highly effective against a broad spectrum of bacteria (both Gram-positive and Gram-negative), viruses, and fungi. Ethanol generally works best at concentrations of 60–80%, while isopropyl alcohol is most effective at 70–90%. Their volatility aids in rapid drying, making them ideal for hand hygiene and pre-procedure skin prep.

Absorption:

• Minimal absorption through intact skin.
• Increased absorption via damaged skin or large-area exposure, especially in infants and children.

Distribution:

• If absorbed systemically, both alcohols are distributed throughout total body water.

Metabolism:

• Ethanol: Primarily metabolized in the liver by alcohol dehydrogenase (ADH) to acetaldehyde, then to acetic acid.
• Isopropyl Alcohol: Metabolized to acetone by ADH.

Elimination Half-life:

• Ethanol: ~1–3 hours
• Isopropyl Alcohol: ~2.5–3 hours

Excretion:

• Primarily renal (urine); also exhaled via lungs and through sweat.

Pregnancy:

• Ethanol and isopropyl alcohol are not recommended for ingestion during pregnancy.
• Topical use is considered safe on intact skin in limited amounts.
• No official FDA pregnancy category is designated for topical application.
• Avoid use on large areas or under occlusion.

Lactation:

• Safe for external use; no significant excretion into breast milk when used appropriately.
• Avoid applying to nipple area to prevent infant exposure via oral contact.

• Primary Class: Topical Antiseptic
• Subclass: Alcohol-Based Disinfectants
• Function: Broad-spectrum antimicrobial agent

• Known hypersensitivity to ethanol or isopropyl alcohol
• Application to open wounds or broken skin in large areas
• Use in neonates and infants <2 months
• Accidental ingestion
• Use on mucous membranes (oral, nasal, genital, ocular areas)
• Concurrent use with oxidizing or reactive agents on the same site

• Highly flammable: Keep away from heat, spark, open flames, or smoking.
• Toxic if ingested: May cause CNS depression, metabolic acidosis, and coma.
• Avoid overuse in children: Risk of systemic absorption and respiratory depression.
• Eye contact: May cause severe irritation or chemical burns.
• Skin drying/irritation: Prolonged or repeated use can lead to dermatitis.
• Inhalation hazard: Avoid prolonged inhalation in confined spaces.
• Poisoning risk: Store out of reach of children to avoid accidental ingestion.

Common (Local Reactions):

• Burning or stinging on application
• Dryness or cracking of skin
• Mild redness or irritation

Uncommon:

• Allergic contact dermatitis
• Skin peeling or blistering (rare)

Serious (with improper use):

• Systemic toxicity: CNS depression, dizziness, hypotension, nausea, vomiting (especially after ingestion)
• Respiratory depression: In infants exposed to high levels
• Metabolic acidosis: With large doses of absorbed isopropyl alcohol

Topical use generally has no systemic interactions.
However, if absorbed systemically:

• Disulfiram: May cause disulfiram-like reactions with ethanol
• CNS depressants: Additive sedation/toxicity when combined (if ingested)
• Metronidazole: Risk of disulfiram-like reaction with ethanol
• Enzyme involvement: Alcohol dehydrogenase (ADH) in the liver metabolizes both agents

Food & Alcohol Interactions:

• Not applicable for external use.
• Avoid co-use with oral ethanol-containing products in children.

• WHO & CDC Guidelines (Hand Hygiene): Endorse alcohol-based hand rubs containing 60–80% ethanol or 70–90% isopropyl alcohol as first-line agents for healthcare worker hand disinfection.
• COVID-19 pandemic response: Accelerated use and formulation standards for hand sanitizers containing this combination; regulated concentrations and labeling requirements updated globally.
• Labeling updates: Emphasis on child-safe packaging and flammability warnings in recent regulatory alerts.

• Temperature: Store between 20°C to 30°C (68°F to 86°F)
• Humidity: Store in a dry place; protect from excess moisture
• Light: Protect from direct sunlight
• Flammability: Store away from ignition sources, flames, and high heat
• Container: Keep tightly closed; use original container
• Handling: Do not mix with bleach or oxidizers
• Child Safety: Keep out of reach of children