국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Seven Three Distilling Company, LLC
TOPICAL
OTC DRUG
- For handwashing to decrease bacteria on the skin - recommended for repeated use Stop use and ask a doctor if skin irritation develops. Antiseptic, Hand Sanitizer
OTC monograph not final
SEVEN THREE HAND SANITIZER- ALCOHOL ANTISEPTIC 70% GEL SEVEN THREE DISTILLING COMPANY, LLC _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._ ---------- 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) (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. Glycerol (1.45% v/v). c. Hydrogen peroxide (0.125% v/v). d. Sterile distilled water or boiled cold water. e. Methacrylic Acid - Ethyl Acrylate Copolymer (5.5% v/v) The firm does add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product. ACTIVE INGREDIENT(S) Ethanol 70%. Purpose: Antiseptic Hydrogen Peroxide <1%. Purpose: Antiseptic US E For handwashing to decrease bacteria on the skin recommended for repeated use WARNINGS For external use only - hands. Flammable. Keep away from heat or flame. When usting this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor if skin irritation develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. WARNINGS for children under 6, use only under adult supervision not recommended for infants avoid contact with broken skin When using this product keep out of eyes. In case of c 전체 문서 읽기