DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]

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DANDRUFF (PYRITHIONE ZINC) SHAMPOO [TOPCO ASSOCIATES LLC]
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NDC 36800-309-13
Set ID 8c155d34-6d19-4b89-b83e-1330453d0c6e
Category HUMAN OTC DRUG LABEL
Packager TOPCO ASSOCIATES LLC
Generic Name
Product Class
Product Number
Application Number PART358H
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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 a Poison Control Center 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, Glycol Distearate, Zinc Carbonate, Sodium Xylenesulfonate, Cocamidopropyl Betaine, Dimethicone, Fragrance (Parfum), Sodium Benzoate, Guar Hydroxypropyltrimonium Chloride, Magnesium Carbonate Hydroxide, Magnesium Sulfate, Benzyl Alcohol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-309-13420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/19/2017
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - APOLLO HEALTH AND BEAUTY CARE INC. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE INC.201901209manufacture(36800-309)
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