Label: CONTROL ANTI-DANDRUFF- pyrithione zinc shampoo, suspension

  • Category: HUMAN OTC DRUG LABEL

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 June 14, 2023

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  • DRUG FACTS

  • ACTIVE INGREDIENT:

    Pyrithione Zinc 2%

    PURPOSE:

    Anti-Dandruff

  • USES:

    helps prevent recurrence of flaking and itching associated with dandruff.

  • WARNING:

    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.

    If swallowed, get medical help or contact a poison control center right away.

  • DIRECTIONS:

    • Apply shampoo and work into a lather.
    • Massage into scalp, leave on for 3-5 minutes.
    • Rinse thoroughly for best results.
    • Use at least twice per week until dandruff is eliminated, or as directed by a pharmacist/physician.

  • INACTIVE INGREDIENTS:

    Aqua (Water/Eau), Sodium Lauroyl Sarcosinate, Sodium Taurine Cocoyl Methyltaurate, Coco-Betaine, Sodium Cocoyl Isethionate, Cocamidopropyl Hydroxysultaine, Sodium Cocoyl Alaninate, Acrylates Copolymer, Cocamidopropyl Betaine, PEG/PPG-120/10 Trimethylolpropane Trioleate, Coco-Glucoside, Hydrogenated Castor Oil, Propanediol, Laureth-2, Parfum (Fragrance), Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Menthol, Tocopheryl Acetate, Glycerin, Limonene, Panthenol, Sodium PCA, Benzyl Benzoate, Hydrolyzed Pea Protein, Hydrolyzed Vegetable Protein, Linalool, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract.

  • QUESTIONS (OR COMMENTS)?

    1-866-924-4247

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CONTROL ANTI-DANDRUFF 
    pyrithione zinc shampoo, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46324-2422
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAURETH-2 (UNII: D4D38LT1L5)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MENTHOL (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46324-2422-0296 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package09/01/202208/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/202208/07/2024
    Labeler - AG Hair Ltd (203691886)
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