Label: ANTIBACTERIAL- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-903-85 - Packager: Personal Care Products LLC
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated October 26, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-903 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN .888 mL in 444 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCO DIETHANOLAMIDE (UNII: 92005F972D) DMDM HYDANTOIN (UNII: BYR0546TOW) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE SODIUM (UNII: MP1J8420LU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29500-903-85 444 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2011 Labeler - Personal Care Products LLC (966155082) Registrant - Personal Care Products LLC (966155082) Establishment Name Address ID/FEI Business Operations Ningbo Pulisi Daily Chemical Products 529047265 manufacture Establishment Name Address ID/FEI Business Operations Ningbo United Group Co Ltd 544900137 manufacture Establishment Name Address ID/FEI Business Operations Ningbo Unichem Household Products Co Ltd 528196956 manufacture