Label: ANTIBACTERIAL liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76162-101-01, 76162-102-01, 76162-103-01 - Packager: Topco Associates 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 September 14, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
Water, Cocoamidopropyl Betaine, Sodium Lauryl Ether Sulphate, Coconut Acid Diethanol Amide, PEG-40 Castor Oil, Sodium Chloride, Phenoxyethanol, Fragrance, Citric Acid, Ethylenediaminetetraacetic Acid Disodium Salt, PEG-600 Stearate, Red 4(C.I. 14700)
DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT RD.
SKOKIE, IL 60077
MADE IN CHINA
© TOPCO JPC1106 - PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL
antibacterial liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan 0.476 mL in 340 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) sodium chloride (UNII: 451W47IQ8X) phenoxyethanol (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-101-01 340 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2006 ANTIBACTERIAL
antibacterial liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan 0.476 mL in 340 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) sodium chloride (UNII: 451W47IQ8X) phenoxyethanol (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-102-01 340 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2006 ANTIBACTERIAL
antibacterial liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength triclosan (UNII: 4NM5039Y5X) (triclosan - UNII:4NM5039Y5X) triclosan 0.476 mL in 340 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCO DIETHANOLAMIDE (UNII: 92005F972D) POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF) sodium chloride (UNII: 451W47IQ8X) phenoxyethanol (UNII: HIE492ZZ3T) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-103-01 340 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2006 Labeler - Topco Associates LLC (006935977) Establishment Name Address ID/FEI Business Operations BBC Group Limited 421270060 MANUFACTURE