c29e65d3-e043-ddbc-e053-2995a90adb2d

SPL v1
SPL
SPL Set ID c29e65d3-e043-ddbc-e053-2995a90adb2d
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (1 mL)
Inactive Ingredients
glycerin water butylene glycol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-08-01
Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Medication Information

Warnings

Flammable. Keep away from fire, flame or high heat.

For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Dispense into hands, rub thoroughly until dry.
Other Information
  • Do not store above 110F (43C)
  • May discolor certain fabriocs or surfaces.
Inactive Ingredients

water (aqua), glycerin, butylene glycol, fragrance (parfum), acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf extract, artemisia argyi leaf extract, cnidium monnieri fruit extract, sargassum fusiforme extract

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

to help reduce bacteria on skin

Section 42229-5

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Avoid contact with broken skin. Do no inhale or ingest.



Stop use and ask a doctor if irritation or redness occurs.



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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

236 mL NDC: 81282-044-01

Structured Label Content

Warnings

Flammable. Keep away from fire, flame or high heat.

For external use only.

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Dispense into hands, rub thoroughly until dry.
Other Information (Other information)
  • Do not store above 110F (43C)
  • May discolor certain fabriocs or surfaces.
Inactive Ingredients (Inactive ingredients)

water (aqua), glycerin, butylene glycol, fragrance (parfum), acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, aloe barbadensis leaf extract, artemisia argyi leaf extract, cnidium monnieri fruit extract, sargassum fusiforme extract

Use

to help reduce bacteria on skin

Section 42229-5 (42229-5)

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Avoid contact with broken skin. Do no inhale or ingest.



Stop use and ask a doctor if irritation or redness occurs.



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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

236 mL NDC: 81282-044-01

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.899580 · Updated: 2026-03-14T22:59:43.649746