País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
TRICLOCARBAN (UNII: BGG1Y1ED0Y) (TRICLOCARBAN - UNII:BGG1Y1ED0Y)
Delta Brands Inc.
TOPICAL
OTC DRUG
Antibacterial ■ for hand washing to decrease bacteria on the skin ■ irritation and redness develops
OTC monograph not final
LUCKY ANTIBACTERIAL DEODORANT- TRICLOCARBAN SOAP DELTA BRANDS 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._ ---------- DRUG FACTS _ACTIVE INGREDIENT_ Triclocarban 0.30% _PURPOSE_ Antibacterial _USES_ ■for hand washing to decrease bacteria on the skin _WARNINGS_ FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT ■avoid contact with eyes. In case of eye contact, flush with water _STOP USE AND ASK A DOCTOR IF_ ■irritation and redness develops KEEP 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 _INACTIVE INGREDIENTS_ sodium palm kernelate, sodium palmate, water, fragrance, glycerin, sodium chloride, tetrasodium EDTA, FD&C yellow no. 5, FD&C red no. 4 PACKAGE LABEL LUCKY ANTIBACTERIAL DEODORANT triclocarban soap PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:20 276 -0 48 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 PALM KERNELATE (UNII: 6 H9 1L1NXTW) SO DIUM PALMITATE (UNII: JQ43KP6 29 6 ) WATER (UNII: 0 59 QF0 KO0 R) Delta Brands Inc. GLYCERIN (UNII: PDC6 A3C0 OX) SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) EDETATE SO DIUM (UNII: MP1J8 420 LU) FD&C YELLO W NO . 5 (UNII: I753WB2F1M) FD&C RED NO . 4 (UNII: X3W0 AM1JLX) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:20 276 -0 48 -30 9 0 g in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct 0 4/15/20 16 2 NDC:20 276 -0 48 -35 10 0 g in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct 0 4/15/20 16 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MA Leer el documento completo