a375f052-b638-33d3-e053-2a95a90a5aaa

Drug Facts

Composition & Product

Active Ingredients

alcohol (1.45 mL)

Inactive Ingredients

glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-04-20

Medication Information

Warnings

For external use on hands only. Flammable. Keep away from fire or flame

Purpose

Antiseptic, Hand Sanitizer

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using.

Other Information

Store below 110°F (43°C)

Inactive Ingredients

glycerin (Glycerol), hydrogen peroxide, Sterile Distilled Water

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

For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended 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 50565-1

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

Section 50566-9

Stop use and ask a doctor if irritation, swelling or redness develops.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, swelling or redness develops.

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

Do Not Use

in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

500 mL NDC: 75504-080-01

Structured Label Content

Warnings

For external use on hands only. Flammable. Keep away from fire or flame

Purpose

Antiseptic, Hand Sanitizer

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry.
Children under 6 years of age should be supervised when using.

Other Information (Other information)

Store below 110°F (43°C)

Inactive Ingredients (Inactive ingredients)

glycerin (Glycerol), hydrogen peroxide, Sterile Distilled Water

Use

For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended 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 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation, swelling or redness develops.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation, swelling or redness develops.

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

Do Not Use (Do not use)

in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

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

500 mL NDC: 75504-080-01

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "1.45", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "0.125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand sanitizer to reduce microorganisms that potentially can cause diseases. Recommended for repeated use.", "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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "50566-9": "Stop use and ask a doctor if irritation, swelling or redness develops.", "50567-7": "When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation, swelling or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use on hands only. Flammable. Keep away from fire or flame", "Directions": "Put enough product in your palm to cover hands and rub hands together briskly until dry. Children under 6 years of age should be supervised when using.", "Do not use": "in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.", "Other information": "Store below 110°F (43°C)", "Active Ingredient(s)": "Alcohol 80% v/v. Purpose: Antiseptic", "Inactive ingredients": "glycerin (Glycerol), hydrogen peroxide, Sterile Distilled Water", "Package Label - Principal Display Panel": "500 mL NDC: 75504-080-01"}