DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.0145 L)

Inactive Ingredients

Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

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

Hand Sanitizer kills harmful bacteria or germs.

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.

Section 50566-9

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

Section 50567-7

For external use only. Keep out of reach of children. When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation develops, discontinue use and consult health care professional.

Warnings

Flammable, keep away from fire, open flame or other sources of heat.

Directions

Occassional use only. Rub thoroughly into hands for at least 30 seconds and allow to dry.

Do Not Use

in children less than 2 years of age

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

4 L NDC: 77427-7427-4

Structured Label Content

Use

Hand Sanitizer kills harmful bacteria or germs.

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

For external use only. Keep out of reach of children. When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation develops, discontinue use and consult health care professional.

Purpose

Antiseptic, Hand Sanitizer

Warnings

Flammable, keep away from fire, open flame or other sources of heat.

Directions

Occassional use only. Rub thoroughly into hands for at least 30 seconds and allow to dry.

Do Not Use (Do not use)

in children less than 2 years of age

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

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)

4 L NDC: 77427-7427-4

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.0145", "strengthDenominator": "1", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "0.00125", "strengthDenominator": "1", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "0.8", "strengthDenominator": "1", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer kills harmful bacteria or germs.", "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.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs.", "50567-7": "For external use only. Keep out of reach of children. When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water. If irritation develops, discontinue use and consult health care professional.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "Flammable, keep away from fire, open flame or other sources of heat.", "Directions": "Occassional use only. Rub thoroughly into hands for at least 30 seconds and allow to dry.", "Do not use": "in children less than 2 years of age", "Other information": "Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active Ingredient(s)": "Alcohol 80% v/v. Purpose: Antiseptic", "Inactive ingredients": "glycerin, hydrogen peroxide, purified water USP", "Package Label - Principal Display Panel": "4 L NDC: 77427-7427-4"}