País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)
International Wholesale, Inc.
TOPICAL
OTC DRUG
Antibacterial - Helps reduce bacteria on the skin that could cause disease. - Recommended for repeated use irritation and redness develops and lasts more than 72 hours.
OTC monograph not final
ANTIBACTERIAL GOLDEN BURST- TRICLOCARBAN SOAP INTERNATIONAL WHOLESALE, 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._ ---------- ACTIVE INGREDIENT Triclocarban 0.30% PURPOS E Antibacterial US ES Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use WARNINGS FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT: do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water. STOP USE AND ASK A DOCTOR IF: irritation and redness develops and lasts more than 72 hours. KEEPS OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Wet bar with water Lather vigorously and wash skin Rinse and dry thoroughly OTHER INFORMATION Store below 110° F (43° C) May discolor certain fabrics or surfaces INACTIVE INGREDIENTS Sodium Cocoate, Sodium Palmate, Water, Glycerin, Sodium Chloride, Titanium Dioxide, BHT, Fragrance, FD&C Yellow #5 PACKAGE DISPLAY ANTIBACTERIAL GOLDEN BURST triclocarban soap PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:528 6 2-120 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH TRICLO CARBAN (UNII: BGG1Y1ED0 Y) (TRICLOCARBAN - UNII:BGG1Y1ED0 Y) TRICLOCARBAN 0 .3 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SO DIUM CO CO ATE (UNII: R1TQH25F4I) SO DIUM PALMATE (UNII: S0 A6 0 0 4K3Z) WATER (UNII: 0 59 QF0 KO0 R) GLYCERIN (UNII: PDC6 A3C0 OX) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) PRODUCT CHARACTERISTICS International Wholesale, Inc. COLOR white S CORE no sco re S HAP E RECTANGLE S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:528 6 2-120 - Leer el documento completo