Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
JFL ENTERPRISES, INC
TOPICAL
OTC DRUG
Decrease bacteria on hands
OTC monograph not final
HAND SANITIZER ORANGE- ALCOHOL GEL JFL ENTERPRISES, 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._ ---------- ANTIBACTERIAL HAND GEL AIR HEADS ORANGE ACTIVE INGREDIENT Alcohol 62% PURPOS E Antiseptic Hand Sanitizer US E Decrease bacteria on hands WARNINGS External Use Only. DO NOT EAT. KEEP OUT OF REACH OF CHILDREN if swallowed get medical help or contact a Poison Control Center right away. DIRECTIONS Rub hands thoroughly with product and allow to dry. INACTIVE INGREDIENT Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Yellow NO.5, Red NO.33 STOP AND ASK A DOCTOR IF Irritation or redness develop. HAND SANITIZER ORANGE HAND SANITIZER ORANGE alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:71246 -50 0 5 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 6 2 mL in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3) WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) CARBO MER HO MO PO LYMER TYPE B ( ALLYL SUCRO SE CRO SSLINKED) (UNII: Z135WT9 20 8 ) TRIETHANO LAMINE 2 -CYCLO HEXYL-4 ,6 -DINITRO PHENO LATE (UNII: N2TK31JIAH) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L) O RANGE (UNII: 5EVU0 4N5QU) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:71246 -50 0 5-1 40 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 1/20 19 0 6 /30 /20 20 MARKETING INFORMATION JFL ENTERPRISES, INC 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 rt333A 0 2/0 1/20 17 0 6 /30 /20 20 LABELER - JFL ENT ERPRISES, INC (010967011) REGISTRANT - JFL ENT ERPRISES, INC (01096701 Read the complete document