Label: TOPCARE GENTLE DANDRUFF DRY SCALP- pyrithione zinc liquid

  • 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 May 1, 2017

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  • Active ingredient

    Pyrithione Zinc 1%

    Purpose

    Anti-dandruff

  • Uses

    to help prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact Poison Control Ceneter immediately.

  • Directions

    • for maximum dandruff control, use every time you shampoo
    • wet hair, massage onto scalp and rinse
    • repeat if desired
  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamide MEA, Glycol Distearate, Dimethicone, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Fragrance (Parfum), Laureth-4, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    TOPCARE  GENTLE DANDRUFF DRY SCALP
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-429
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURETH-4 (UNII: 6HQ855798J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-429-13420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/28/2017
    Labeler - TopCo Associates LLC (006935977)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(36800-429)
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