Label: FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH- chloroxylenol solution
- NDC Code(s): 11429-1010-1, 11429-1010-3, 11429-1010-7, 11429-1010-8
- Packager: Woodbine Products Company
- 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 November 20, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH
chloroxylenol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11429-1010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DMDM HYDANTOIN (UNII: BYR0546TOW) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11429-1010-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2018 2 NDC:11429-1010-7 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2018 3 NDC:11429-1010-3 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2018 4 NDC:11429-1010-8 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/20/2018 Labeler - Woodbine Products Company (004220323) Establishment Name Address ID/FEI Business Operations Woodbine Products Company 004220323 manufacture(11429-1010)