Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Calego International Inc.
OTC DRUG
for handwashing to decrease bacteria on the skin
OTC monograph not final
IFLYSMART GERM-FREE KIT- ALCOHOL CALEGO INTERNATIONAL 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._ ---------- IFLYSMART GERM-FREE KIT _DRUG FACTS_ _ACTIVE INGREDIENT_ Ethyl Alcohol 75% _PURPOSE_ Antibacterial _USE_ for handwashing to decrease bacteria on the skin _WARNINGS_ FOR EXTERNAL USE ONLY. DO NOT USE in the eyes STOP USE AND ASK A DOCTOR IF irritation and redness develop condition persists for more than 72 hours KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away _DIRECTIONS_ wet hands thoroughly with product and allow to dry without wiping _INACTIVE INGREDIENTS_ Aqua, Capom, Triethanolamine _QUESTIONS OR COMMENTS?_ To report a serious adverse event, contact 1-800-334-4577 KIT PACKAGE LABEL IFLYSMART GERM-FREE KIT alcohol kit PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:7248 7-0 0 5 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7248 7-0 0 5-0 0 1 in 1 KIT 0 5/0 1/20 20 QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 1 BOTTLE 6 0 mL PART 1 OF 1 ANTIBACTERIAL HAND alcohol gel Calego International Inc. PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:7248 7-0 0 6 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 V9 0 M) ALCOHOL 0 .75 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) TRO LAMINE (UNII: 9 O3K9 3S3TK) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7248 7-0 0 6 -0 2 6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333E 0 5/0 1 Lees het volledige document