6193af2e-94be-4e85-8d70-c201836832aa

SPL v1
SPL
SPL Set ID 6193af2e-94be-4e85-8d70-c201836832aa
Route
topical
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (75 mL)
Inactive Ingredients
water hydrogen peroxide

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-07-27
Purpose

Antiseptic

Description

Alcohol 75% v/v.

Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

on children under 2 months old

or on open skin wounds.

When using this product keep out of eyes, ears, mouth. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Use when soap and water are not available.

Purpose

Antiseptic

Directions

Place enough sanitizer on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years old when using this product to avoid swallowing.

Inactive Ingredients

Hydrogen peroxide, USP purified water.

Description

Alcohol 75% v/v.

Section 50565-1

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

Product Label

Active Ingredient

Alcohol 75% v/v.

Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

on children under 2 months old

or on open skin wounds.

When using this product keep out of eyes, ears, mouth. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. Use when soap and water are not available.

Purpose

Antiseptic

Directions

Place enough sanitizer on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years old when using this product to avoid swallowing.

Inactive Ingredients (Inactive ingredients)

Hydrogen peroxide, USP purified water.

Section 50565-1 (50565-1)

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

Product Label (Product label)

Active Ingredient

Alcohol 75% v/v.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.226591 · Updated: 2026-03-14T22:58:05.187766