SPL v1
SPL
SPL Set ID 23c7143e-2578-4ddb-90d1-002031bcfb27
Route
TOPICAL
Published
Effective Date 2020-05-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-03
Description

Ethyl Alcohol 80% v/v

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 80% v/v

Use

For handwashing to decrease bacteria on the skin

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Directions

Wet hands thoroughly with products and allow to dry without wiping.

For children under six years, use only under adult supervision.

Not recommended for infants.

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredients

Glycerol, hydrogen peroxide, sterile distilled water or boiled cold water, scent, rapid gel

Package Label Principal Display Panel

Structured Label Content

Use

For handwashing to decrease bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat or flame

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Directions

Wet hands thoroughly with products and allow to dry without wiping.

For children under six years, use only under adult supervision.

Not recommended for infants.

Active Ingredient

Ethyl Alcohol 80% v/v

Inactive Ingredients (Inactive ingredients)

Glycerol, hydrogen peroxide, sterile distilled water or boiled cold water, scent, rapid gel

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:38.247824 · Updated: 2026-03-14T22:56:52.375130