Label: ANTIBACTERIAL- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50157-203-14 - Packager: Brands International Corp
- 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 May 6, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-203 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.15 mg in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-203-14 414 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/06/2016 Labeler - Brands International Corp (243748238) Establishment Name Address ID/FEI Business Operations Brands International Corp 243748238 manufacture(50157-203)