Label: TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH- selenium sulfide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-618-14 - 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 July 29, 2014
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- ACTIVE INGREDIENT
- USES
- WARNINGS
- DIRECTIONS
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INACTIVE INGREDIENTS
WATER (AQUA), AMMONIUM LAURETH SULFATE, AMMONIUM LAURYL SULFATE, GLYCOL DISTEARATE, COCAMIDE MEA, AMMONIUM XYLENESULFONATE, ACRYLATES COPOLYMER, SODIUM HYDROXIDE, SODIUM CITRATE, FRAGRANCE (PARFUM), DIMETHICONE, CETYL ALCOHOL, SODIUM CHLORIDE, CITRIC ACID, SODIUM BENZOATE, STEARYL ALCOHOL, DISODIUM EDTA, HYDROXYPROPYL METHYLCELLULOSE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, RED 4 (CI 14700)
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INGREDIENTS AND APPEARANCE
TOPCARE GENTLE DANDRUFF CLINICAL STRENGTH
selenium sulfide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-618 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) AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) GLYCOL DISTEARATE (UNII: 13W7MDN21W) COCO MONOETHANOLAMIDE (UNII: C80684146D) AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CITRATE (UNII: 1Q73Q2JULR) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C RED NO. 4 (UNII: X3W0AM1JLX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-618-14 420 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/28/2014 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(36800-618)