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 Medek, Llc. 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 using only the following United States Pharmacopoeia (USP) grade ingredients:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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 (.5% v/v).
- Carbopol (0.5% v/v).
- Triethanolamine (0.4% v/v)
- Sterile distilled water or boiled cold water.
Active Ingredient(S)
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Antiseptic Hand Sanitizer to reduce germs on skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from open flame and sources of heat.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
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, rash or redness 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.
Otc - Stop Use
Stop use and ask a doctor if irritation, rash or redness occurs. These may be signs of a serious condition.
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.
Directions
Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store below 110F (43C)
- Avoid freezing. May discolor certain fabrics/surfaces.
Inactive Ingredients
Water, glycerin, carbopol, Triethanolamine, Propylene glycol
Package Label - Principal Display Panel
976 mL NDC: 75432-003-01
3786 mL NDC: 75432-003-02
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