FDA Label for Lifewise Hand Sanitizer
View Indications, Usage & Precautions
Lifewise Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product General Wireless Operations 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)
Ethyl Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
To help reduce germs and bacteria that can potentially cause disease and illness.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
Do not use on children less than 2 months of age or on open skin wounds.
Otc - When Using
Keep away from eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.
Otc - Stop Use
If irritation or rash occurs, stop use and consult a doctor. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Apply directly to hands. Rub hands together until dry.
Other Information
Store between 59-86°F (15-30°C). May discolor fabrics and surfaces.
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Recent Major Changes
Update and clarify use cases, warnings, and directions of use.
Package Label - Principal Display Panel
236 mL NDC: 80019-520-02
Catalog No. 6405202
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