a3d0e7ee-84d9-bbb8-e053-2995a90a053b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
Purpose
Antiseptic, Hand Sanitzer
Medication Information
Purpose
Antiseptic, Hand Sanitzer
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
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:
- 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 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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Warnings
For external use only. Flammable. Keep away from heat or flame
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.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Inactive Ingredients
glycerin, triethanolamine, carbomer 940, purified water USP
Package Label Principal Display Panel
120 mL NDC: 75477-435-12
250 mL NDC: 75477-435-25
500 mL NDC: 75477-435-50
02 mL NDC: 75477-435-02
1000 L NDC: 75477-435-10
Structured Label Content
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:
- 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 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 keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Purpose
Antiseptic, Hand Sanitzer
Warnings
For external use only. Flammable. Keep away from heat or flame
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.
Do Not Use (Do not use)
- in children less than 2 months of age
- on open skin wounds
Other Information (Other information)
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Inactive Ingredients (Inactive ingredients)
glycerin, triethanolamine, carbomer 940, purified water USP
Package Label Principal Display Panel (Package Label - Principal Display Panel)
120 mL NDC: 75477-435-12
250 mL NDC: 75477-435-25
500 mL NDC: 75477-435-50
02 mL NDC: 75477-435-02
1000 L NDC: 75477-435-10
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:57:46.368975 · Updated: 2026-03-14T22:57:01.531445