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 Klm Promo Products, 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 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 62%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Decrease bacteria and germs on the hands
when water, soap, and towel are not available
recommended for repeated use
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
Do not use in ears and mouth
Otc - When Using
When using this product avoid contact with eyes. In case of contact flush eyes with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develops or persists.
Otc - Keep Out Of Reach Of Children
Children under 6, use only under adult supervision. Not recommended for infants.
Directions
- pump as needed on to your palms and thoroughly spread on both hands
- rub into skin until dry
Other Information
- store at 20℃(68℉-77℉)
- may discolor fabrics
Inactive Ingredients
Purified Water, Triethanolamine, Glycerin, Disodium EDTA, carbomer
Package Label - Principal Display Panel
30 mL NDC: 77165-300-01
antibacterial hand sanitizer
1 fl.oz. (30ml)
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