Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
World Famous Tattoo Inc.
TOPICAL
OTC DRUG
Antiseptic Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC monograph not final
WORLD FAMOUS HAND SANITIZER- ALCOHOL SOLUTION WORLD FAMOUS TATTOO INC. _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- WORLD FAMOUS HAND SANITIZER 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: a. 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. b. Glycerol (1.45% v/v). c. Hydrogen peroxide (0.125% v/v). d. 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_ Alcohol 80% v/v _PURPOSE_ Antiseptic _USE[S]:_ Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. _WARNINGS:_ FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME DO NOT USE 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 A DOCTOR if irritation or rash 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. _DIRECTIONS:_ Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when u Read the complete document