Label: HANDSOAP- triclosan liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 37012-243-96, 37012-243-97 - Packager: ShopKo Stores Operating Co., 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 July 8, 2013
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INGREDIENTS AND APPEARANCE
HANDSOAP
triclosan liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-243 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.545 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM CHLORIDE (UNII: 451W47IQ8X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCERIN (UNII: PDC6A3C0OX) PEG-18 GLYCERYL OLEATE/COCOATE (UNII: VD2D270332) COCO MONOETHANOLAMIDE (UNII: C80684146D) DMDM HYDANTOIN (UNII: BYR0546TOW) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID ACETATE (UNII: DSO12WL7AU) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-243-97 1892 mL in 1 BOTTLE, PLASTIC 2 NDC:37012-243-96 221 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/10/2009 Labeler - ShopKo Stores Operating Co., LLC (023252638) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(37012-243)