国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Consolidated Chemicals, LLC
TOPICAL
OTC DRUG
Antiseptic, Hand Sanitizer 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
HAND SANITIZER- ALCOHOL GEL CONSOLIDATED CHEMICALS, 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._ ---------- 80% ALCOHOL GEL SANITIZER HAND SANITIZER ALCOHOL GEL This hand sanitizer is manufactured using the following ingredients in the preparation of the product (wt% in final product formulation) consistent with 21 CFR Part 310: a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80 wt%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. b. Glycerol USP Grade (2 wt%). c. Hydrogen peroxide (0.14 wt%). d. Hydroxypropyl methylcellulose USP (0.75 wt%) e. Distilled water The firm does not add other active or inactive ingredients. ACTIVE INGREDIENT(S) Alcohol 80%. Purpose: Antiseptic PURPOSE Antiseptic, Hand Sanitizer USE 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. 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 using this product to avoid swallowing. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (1 阅读完整的文件