Label: ANTI-BACTERIAL FOAMING- triclosan soap
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Contains inactivated NDC Code(s)
NDC Code(s): 49852-016-08 - Packager: Tri-Coastal Design Company Inc.
- 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 August 12, 2011
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- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Other information
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ANTI-BACTERIAL FOAMING
triclosan soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49852-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.1 mL in 100 mL Inactive Ingredients Ingredient Name Strength BENZOPHENONE (UNII: 701M4TTV9O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCO DIETHANOLAMIDE (UNII: 92005F972D) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49852-016-08 240 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 08/15/2011 Labeler - Tri-Coastal Design Company Inc. (609734900) Establishment Name Address ID/FEI Business Operations Guangzhou St Eva Fine Chemical Co Ltd 528039793 manufacture