a5958d0b-cfac-6797-e053-2a95a90a6093

Drug Facts

Composition & Product

Active Ingredients

alcohol (75 mL)

Inactive Ingredients

hyaluronate sodium 1,2-hexanediol glycerin butylene glycol water aloe vera leaf levomenthol carbomer homopolymer type b (allyl pentaerythritol crosslinked) trolamine

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-18

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product on your palm to cover all surfaces and rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Avoid freezing and excessive heat above 40C (104F)
May discolor certain fabrics or surface

Inactive Ingredients

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

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 to help reduce bacteria on the skin.

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 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 eye. In case of contact with eyes, rinse thoroughly with water.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product on your palm to cover all surfaces and rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

Avoid freezing and excessive heat above 40C (104F)
May discolor certain fabrics or surface

Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol

Use

Hand Sanitizer to help reduce bacteria on the skin.

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 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 eye. In case of contact with eyes, rinse thoroughly with water.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "Hand Sanitizer to help reduce bacteria on the skin.", "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 right away.", "50566-9": "Stop use and ask a doctor if irritation or rash appears and lasts.", "50567-7": "When using this product do not use in or near the eye. In case of contact with eyes, rinse thoroughly with water.", "Purpose": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame.", "Directions": "Place enough product on your palm to cover all surfaces and rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Other information": "Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surface", "Active Ingredient(s)": "Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol"}