国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)
Grupo Yacana Mexico SAS de CV
TOPICAL
OTC DRUG
Antiseptic Hand sanitizer to help reduce bacteria that potentially can cause disease, For use when soap and water are not available
OTC monograph not final
YACANA ISOPROPYL ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION- ALCOHOL GEL GRUPO YACANA MEXICO SAS DE CV _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._ ---------- ACTIVE INGREDIENT Isopropyl Alcohol 70% v/v. PURPOS E Antiseptic US ES 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 Center right away. DIRECTIONS Place enough product to cover all surfaces, rub hand together until dry, Supervise children under 6 years of age when using this product to avoid swallowing OTHER INFORMATION: Store between 15-30°C (59-86F). Avoid Freezing and excessive heat above 40°C (104F) INACTIVE INGREDIENTS Glycerin, Hydrogen Peroxide, Purified Water USP PACKAGE LABEL - PRINCIPAL DISPLAY PANEL YACANA ISOPROPYL ALCOHOL ANTISEPTIC 70% TOPICAL SOLUTION alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:76 59 2-0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL - UNII:ND2M416 30 2) ISOPROPYL ALCOHOL 70 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH GLYCERIN (UNII: PDC6 A3C0 OX) HYDRO GEN PERO XIDE (UNII: BBX0 6 0 AN9 V) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:76 59 2-0 0 1- 250 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co m 阅读完整的文件