a6b310ed-bf40-f4d3-e053-2995a90a08f3

Drug Facts

Composition & Product

Active Ingredients

alcohol (80 mL)

Inactive Ingredients

glycerin carbomer homopolymer type b (allyl pentaerythritol crosslinked) water lemon oil aminomethylpropanol hyaluronate sodium aloe vera leaf citrus paradisi seed green tea leaf

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-05-28

Medication Information

Warnings

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

Purpose

Antiseptic

Directions

Place enough product on your palm to thoroughly cover your hands.
Rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Other Information

Store between 15-30C (59-86F)
May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Citrus Limon (Lemon) Fruit Extract, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Citrus Paradisi Seed, Camellia Sinensis Leaf Extract, Sodium Hyaluronate

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 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

Structured Label Content

Warnings

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

Purpose

Antiseptic

Directions

Place enough product on your palm to thoroughly cover your hands.
Rub hands together briskly until dry.
Children under 6 years of age should be supervised when using this product.

Other Information (Other information)

Store between 15-30C (59-86F)
May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water, Citrus Limon (Lemon) Fruit Extract, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Citrus Paradisi Seed, Camellia Sinensis Leaf Extract, Sodium Hyaluronate

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 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)

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 eyes. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire or flame.", "Directions": "Place enough product on your palm to thoroughly cover your hands. Rub hands together briskly until dry. Children under 6 years of age should be supervised when using this product.", "Other information": "Store between 15-30C (59-86F) May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Alcohol 80% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, Citrus Limon (Lemon) Fruit Extract, Carbomer, Glycerin, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Citrus Paradisi Seed, Camellia Sinensis Leaf Extract, Sodium Hyaluronate"}