Hand Sanitizer

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.005 mL)

Inactive Ingredients

Triethanolamine Tris(dihydrogen Phosphate) Glycerin Hydrogen Peroxide Water Peg-10 Acrylate/perfluorohexylethyl Acrylate Copolymer

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-06

Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a hand sanitizer manufactured per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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): Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) Glycerin 98% (0.015% v/v). Hydrogen peroxide 3% (0.04% v/v). Sterile distilled water or boiled cold water (19.9% v/v). Acrylates Copolymer (rheology modifier) (0.05% v/v). Triethanolamine (pH neutralizer) (0.005% v/v).

Uses

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 per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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):

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
Glycerin 98% (0.015% v/v).
Hydrogen peroxide 3% (0.04% v/v).
Sterile distilled water or boiled cold water (19.9% v/v).
Acrylates Copolymer (rheology modifier) (0.05% v/v).
Triethanolamine (pH neutralizer) (0.005% v/v).

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 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 thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

Place enough product on hands to cover all surfaces. Rub 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 between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Inactive Ingredients

Purified water USP, acrylates copolymer, hydrogen peroxide, glycerin, triethanolamine

Package Label Principal Display Panel

Structured Label Content

Uses

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 per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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):

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v))
Glycerin 98% (0.015% v/v).
Hydrogen peroxide 3% (0.04% v/v).
Sterile distilled water or boiled cold water (19.9% v/v).
Acrylates Copolymer (rheology modifier) (0.05% v/v).
Triethanolamine (pH neutralizer) (0.005% v/v).

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 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 thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

Place enough product on hands to cover all surfaces. Rub 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 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)

Purified water USP, acrylates copolymer, hydrogen peroxide, glycerin, triethanolamine

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

Advanced Ingredient Data

[{"name": "TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)", "unii": "36YHT392ID", "classCode": "IACT", "strengthNumerator": "0.005", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "0.04", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "19.9", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PEG-10 ACRYLATE/PERFLUOROHEXYLETHYL ACRYLATE COPOLYMER", "unii": "D76Z87928N", "classCode": "IACT", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "42229-5": "This is a hand sanitizer manufactured per guidance outlined in the final ruling of 21 CFR Part 310- Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. 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): Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) Glycerin 98% (0.015% v/v). Hydrogen peroxide 3% (0.04% v/v). Sterile distilled water or boiled cold water (19.9% v/v). Acrylates Copolymer (rheology modifier) (0.05% v/v). Triethanolamine (pH neutralizer) (0.005% v/v).", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash 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 thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "Place enough product on hands to cover all surfaces. Rub 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 between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)", "Active Ingredient(s)": "Alcohol 80% v/v. Purpose: Antiseptic", "Inactive ingredients": "Purified water USP, acrylates copolymer, hydrogen peroxide, glycerin, triethanolamine"}