国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Fareva Morton Grove, Inc.
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 FAREVA MORTON GROVE, 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._ ---------- a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (78%, 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 (1.72% v/v). c. Hydroxypropylcellulose (1.28% v/v). d. Sterile distilled water or boiled cold water. ACTIVE INGREDIENT(S) Alcohol 78% v/v. Purpose: Antiseptic PURPOS E Antiseptic, Hand Sanitizer US E 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. If 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 using this product to avoid swallowing. OTHER INFORMATION Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F) May discolor certain fabrics or surfaces INACTIVE INGREDIENTS glycerin, hydroxypropylcellulose, water PACKAGE LABEL - PRINCIPAL DISPLAY PANEL 500 mL NDC: 72686-180-14 Yoomi 16-9 label.jpg HAND SANITIZER alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:726 8 6 -18 0 (NDC:78 46 9 -0 0 1) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 阅读完整的文件