Label: TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN- pyrithione zinc liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-424-14 - 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 28, 2014
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- ACTIVE INGREDIENT
- USES
- WARNINGS
- DIRECTIONS
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INACTIVE INGREDIENTS
WATER (AQUA), SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM CHLORIDE, GLYCOL DISTEARATE, ZINC CARBONATE, COCAMIDOPROPYL BETAINE, FRAGRANCE (PARFUM), DIMETHICONE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM BENZOATE, CITRIC ACID, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)
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INGREDIENTS AND APPEARANCE
TOPCARE 2 IN 1 DANDRUFF EVERYDAY CLEAN
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-424 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCOL DISTEARATE (UNII: 13W7MDN21W) ZINC CARBONATE (UNII: EQR32Y7H0M) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM XYLENESULFONATE (UNII: G4LZF950UR) MAGNESIUM SULFATE (UNII: DE08037SAB) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A) MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4) BENZYL ALCOHOL (UNII: LKG8494WBH) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 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:36800-424-14 420 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 07/27/2014 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(36800-424)