a8fd312b-e801-1ec3-e053-2995a90a6670
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 Sanitizer
Medication Information
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.
Use
Sanitizer to help reduce bacteria on the skin that could cause disease. Recommeded for repeated use
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 43683-2
Warnings:
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses:
- Sanitizer to help reduce bacteria on the skin that could cause diease
- Recommended for repeated use
Directions:
- Place enough product in your palm to thoroughly cover your hands
- Rub hands together briskly unitl dry
- Children under 6 years of age should be supervised when using this 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 appears and lasts
Section 50567-7
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Flammable. Keep away from fire or flame. For external use only.
Directions
- Place enough product in your palm to thoroughly cover your hands.
- Rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using this product
Do Not Use
- for children less than 2 months of age
- on open skin wounds.
Other Information
- Store below 110 oF (43 oC)
- May discolor certain fabrics or surfaces
Active Ingredient(s)
Alcohol 80% v/v. Purpose: Antiseptic
Inactive Ingredients
Glycerin, hydrogen peroxide, purified water USP
Package Label Principal Display Panel
18900 mL NDC: 77183-5195-0
18900mL in ONE PAIL
Structured Label Content
Use
Sanitizer to help reduce bacteria on the skin that could cause disease. Recommeded for repeated use
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 43683-2 (43683-2)
Warnings:
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses:
- Sanitizer to help reduce bacteria on the skin that could cause diease
- Recommended for repeated use
Directions:
- Place enough product in your palm to thoroughly cover your hands
- Rub hands together briskly unitl dry
- Children under 6 years of age should be supervised when using this 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 appears and lasts
Section 50567-7 (50567-7)
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose
Antiseptic, Hand Sanitizer
Warnings
Flammable. Keep away from fire or flame. For external use only.
Directions
- Place enough product in your palm to thoroughly cover your hands.
- Rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using this product
Do Not Use (Do not use)
- for children less than 2 months of age
- on open skin wounds.
Other Information (Other information)
- Store below 110 oF (43 oC)
- May discolor certain fabrics or surfaces
Active Ingredient(s)
Alcohol 80% v/v. Purpose: Antiseptic
Inactive Ingredients (Inactive ingredients)
Glycerin, hydrogen peroxide, purified water USP
Package Label Principal Display Panel (Package Label - Principal Display Panel)
18900 mL NDC: 77183-5195-0
18900mL in ONE PAIL
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:58:05.459275 · Updated: 2026-03-14T22:57:27.471846