Label: ANTIBACTERIAL- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50157-201-24 - Packager: Brands International Corp
- 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 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
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INACTIVE INGREDIENT
Inactive Ingredients - Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Aloe Barbadensis Leaf Extract, Tocopheryl (Vitamin E) Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (Cl 19140), Red 4 (Cl 14700)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50157-201 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 METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM CHLORIDE (UNII: 451W47IQ8X) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAUROAMPHOACETATE (UNII: SLK428451L) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) GLYCERIN (UNII: PDC6A3C0OX) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50157-201-24 709 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(50157-201)