FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Alfa Vitamins Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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.
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Directions
Place enough product in your to thoroughly covere hands
Rub hands together briskly until mdry
Children under 6 years of age should be supervised when using the product
- Place enough product in your palm to thoroughly cover hands
- Rub hands together briskly until dry
- Children under 6 years of age should be supervised when using this product
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- Do not get into eyes
- If contact occurs, rinse eyes throughly with water
Otc - When Using
Do not get into eyes
If contact occurs, rinse eyes throughly with water
Otc - Stop Use
Irritation or rash appears and lasts
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other Information
- Store below 110F (43C)
- May discolor certain fabrics or surfaces
Inactive Ingredients
Aloe Vera, Carbomer, Fragrance, Glycerin, Methyl Gluceth-20, Purief Water, Propylene Glycol, Triethanolamine
Package Label - Principal Display Panel
472 mL NDC: 13298-156-16
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