Label: TOPCARE MEDICATED DANDRUFF- selenium sulfide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-719-11 - Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 18, 2014
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INGREDIENTS AND APPEARANCE
TOPCARE MEDICATED DANDRUFF
selenium sulfide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-719 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) TEA-LAURYL SULFATE (UNII: E8458C1KAA) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) AMMONIUM CHLORIDE (UNII: 01Q9PC255D) DMDM HYDANTOIN (UNII: BYR0546TOW) MENTHOL (UNII: L7T10EIP3A) SODIUM HYDROXIDE (UNII: 55X04QC32I) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) HYPROMELLOSES (UNII: 3NXW29V3WO) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-719-11 325 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 11/17/2014 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209) Establishment Name Address ID/FEI Business Operations APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(36800-719)