País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Shalom International Corp
TOPICAL
OTC DRUG
To decrease bacteria on the skin and clean hands. Recommended for repeated use.
OTC monograph not final
SPATHERAPY ANTIBACTERIAL PINEAPPLE- ALCOHOL GEL SHALOM INTERNATIONAL CORP _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._ ---------- SPATHERAPY ANTIBACTERIAL HAND GEL PINEAPPLE _DRUG FACTS_ _ACTIVE INGREDIENT_ Alcohol Denat. 62% _PURPOSE_ Antibacterial _USE_ To decrease bacteria on the skin and clean hands. Recommended for repeated use. _WARNINGS_ FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FLAMES. WHEN USING THIS PRODUCT do not get into eye. If contact occurs, rinse thoroughly with water. STOP USE AND ASK A DOCTOR IF irritation or redness develop or persists for more than 72 hours KEEP OUT OF REACH OF CHILDREN. _DIRECTIONS_ Apply to hands until thoroughly wet. Rub vigorously until dry. _INACTIVE INGREDIENTS_ Water, PEG-40 Hydrogenated Cater Oil, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer. DMDM Hydantoin, Fragrance (Parfum), Sodium Hydroxide, Tocopherol Acetate. FD&C Yellow 5, FD&C Blue 1. PACKAGE LABELING: SPATHERAPY ANTIBACTERIAL PINEAPPLE alcohol gel PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:730 25-152 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 .6 2 mL in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) PO LYO XYL 4 0 HYDRO GENATED CASTO R O IL (UNII: 7YC6 8 6 GQ8 F) CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO) DMDM HYDANTO IN (UNII: BYR0 546 TOW) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) .ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) FD&C BLUE NO . 1 (UNII: H3R47K3TBD) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:730 25-152-0 1 30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 12/0 1/20 20 MARKETING INFORMATION Leer el documento completo