The following Structured Product Label (SPL) was submitted to the FDA by Kepter Mexico S.a De C.v for the product Hand Sanitizer (NDC 78391-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:
a. Alcohol (ethanol) (USP of 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.
b. Glycerin (.5% v/v).
c. Carbopol (.5% v/v).
d. Triethanolamine (.4% v/v).
e. Sterile distilled water or boiled cold water.
Ethyl Alcohol 70% v/v. Purpose: Antiseptic
Active Ingredient(s)
Antiseptic Hand Sanitizer to reduce germs on the skin. For use when soap and water not available.
For external use only. Flammable. Keep away from open flame and sources of heat.
in children less than 2 months of age. On open skin wounds.
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 doctor: If irritation, rash or redness ocurrs. These may be signs of a serious condition.
Keep out reach of children: If swallowed, get medical help or contat a Posion Control Center right away.
Stop use and ask 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 Posion Control Center right away.
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.
Store below 110F (43C)
Avoid freezing. May discolor certain fabrics/surfaces.
Water, Glycerin, Carbopol, Triethanolamine, Propylene glycol
976 ml NDC: 78391-001-01
3786 ml NDC: 78391-001-02
* Please review the disclaimer below.
