Label: PERSONAL CARE ANTIBACTERIAL HAND- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 29500-9038-6 - Packager: Personal Care Products, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 June 13, 2011
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- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PERSONAL CARE ANTIBACTERIAL HAND
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-9038 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.2 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) AMMONIUM CHLORIDE (UNII: 01Q9PC255D) LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38) 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:29500-9038-6 221 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/11/2011 Labeler - Personal Care Products, LLC (966155082) Establishment Name Address ID/FEI Business Operations Ningbo Liyuan Daily Chemical Products Co Ltd 530766098 manufacture