Hand Sanitizer Liquid

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.05 mL)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Propanediol 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

* Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged 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 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 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-
When using this product keep out o f eyes. In case of contact, flush with water several minutes.
Keep out of reach of children except under adult supervision
If swalow get medical help or contact a Poison Control Center right away.
Flammable: Keep away from heat and flame.
Stop use and ask Doctor: if skin irritation develops.
Do not swalow
Children under 6 years old should be supervised when using this product

Directions

Place enough product in your palm to throughly cover your hands.
Rub hands together briskly until dry
Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry

Do Not Use

Stop use and ask a doctor if

* Irritation develops

Other Information

QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, water. citric acid, propanediol

Package Label Principal Display Panel

Structured Label Content

Use

* Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged 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 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 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-
When using this product keep out o f eyes. In case of contact, flush with water several minutes.
Keep out of reach of children except under adult supervision
If swalow get medical help or contact a Poison Control Center right away.
Flammable: Keep away from heat and flame.
Stop use and ask Doctor: if skin irritation develops.
Do not swalow
Children under 6 years old should be supervised when using this product

Directions

Place enough product in your palm to throughly cover your hands.
Rub hands together briskly until dry
Apply it on the parts of the body that needs to be cleaned and rub it briskly until dry

Do Not Use (Do not use)

Stop use and ask a doctor if

* Irritation develops

Other Information (Other information)

QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, water. citric acid, propanediol

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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