hand sanitizer

hand sanitizer
SPL v1
SPL
SPL Set ID a5615d8b-8836-39b1-e053-2a95a90af214
Route
topical
Published
Effective Date 2020-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
isopropyl alcohol (1.45 mL)
Inactive Ingredients
glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-05-15
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: Isopropyl Alcohol (75%, 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

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact poison center right way.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

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: Isopropyl Alcohol (75%, 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

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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:

  • Isopropyl Alcohol (75%, 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 away from Children & pets.

Section 50566-9

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

Section 50567-7

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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
540 Ml Label

540 ML NDC: 77320-786-18

3840 Ml Label

3840 ml NDC: 77320-786-01

70 Ml Bottle Back

70 ml NDC: 77320-786-70

540 Ml Bottle Back

540 ml NDC: 77320-786-18

70 Ml Bottle Front

70 ml NDC: 77320-786-70

3840 Ml Gallon Back

3840 ml NDC : 77320-786-01

540 Ml Bottle Front

540 ml NDC: 77320-786-18

3840 Ml Gallon Front

3840 ml NDC: 77320-786-01

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

70 Ml Ndc: 77320 786 70

70 ml NDC: 77320-786-70

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed, get medical help or contact poison center right way.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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:

  • Isopropyl Alcohol (75%, 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 away from Children & pets.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
540 Ml Label (540 ml LABEL)

540 ML NDC: 77320-786-18

3840 Ml Label (3840 ml LABEL)

3840 ml NDC: 77320-786-01

70 Ml Bottle Back (70 ml BOTTLE BACK)

70 ml NDC: 77320-786-70

540 Ml Bottle Back (540 ml BOTTLE BACK)

540 ml NDC: 77320-786-18

70 Ml Bottle Front (70 ml BOTTLE FRONT)

70 ml NDC: 77320-786-70

3840 Ml Gallon Back (3840 ml GALLON BACK)

3840 ml NDC : 77320-786-01

540 Ml Bottle Front (540 ml BOTTLE FRONT)

540 ml NDC: 77320-786-18

3840 Ml Gallon Front (3840 ml GALLON FRONT)

3840 ml NDC: 77320-786-01

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

70 Ml Ndc: 77320 786 70 (70 ml NDC: 77320-786-70)

70 ml NDC: 77320-786-70

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:35.163409 · Updated: 2026-03-14T22:56:48.082967