Hand Sanitizer

Drug Facts

Composition & Product

Active Ingredients

Alcohol (28 mL)

Inactive Ingredients

Water Glycerin Trolamine Carbomer 940

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-29

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerin (.5% v/v). c. Carbopol (.5% v/v). d. Triethanolamine (.4% v/v). e. Sterile distilled water or boiled cold water.

Use

Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.

Section 42229-5

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerin (.5% v/v).

c. Carbopol (.5% v/v).

d. Triethanolamine (.4% v/v).

e. Sterile distilled water or boiled cold water.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Section 50566-9

Stop use and ask doctor: If irritation, rash or redness 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.

Stop use and ask doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.

Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.

Warnings

For external use only. Flammable. Keep away from open flame and sources of heat.

Directions

Apply a small amount of product into hands and rub between both sides of hands 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 below 110F (43C)

Avoid freezing. May discolor certain fabrics/surfaces.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerin, Carbopol, Triethanolamine

Package Label Principal Display Panel

976 ml NDC: 78391-001-01

3786 ml NDC: 78391-001-02

Structured Label Content

Use

Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.

Section 42229-5 (42229-5)

This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

b. Glycerin (.5% v/v).

c. Carbopol (.5% v/v).

d. Triethanolamine (.4% v/v).

e. Sterile distilled water or boiled cold water.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor: If irritation, rash or redness 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.

Stop use and ask doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.

Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from open flame and sources of heat.

Directions

Apply a small amount of product into hands and rub between both sides of hands 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 below 110F (43C)

Avoid freezing. May discolor certain fabrics/surfaces.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, Glycerin, Carbopol, Triethanolamine

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

976 ml NDC: 78391-001-01

3786 ml NDC: 78391-001-02

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "28", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.", "42229-5": "This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients: a. Alcohol (ethanol) (USP of Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerin (.5% v/v). c. Carbopol (.5% v/v). d. Triethanolamine (.4% v/v). e. Sterile distilled water or boiled cold water.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.", "50566-9": "Stop use and ask doctor: If irritation, rash or redness occurs. These may be signs of a serious condition.", "50567-7": "When using this product: Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition. Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from open flame and sources of heat.", "Directions": "Apply a small amount of product into hands and rub between both sides of hands 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 below 110F (43C) Avoid freezing. May discolor certain fabrics/surfaces.", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v. Purpose: Antiseptic", "Inactive Ingredients": "Water, Glycerin, Carbopol, Triethanolamine", "Package Label - Principal Display Panel": "976 ml NDC: 78391-001-01 3786 ml NDC: 78391-001-02"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information