Label: DZUL ANTI-DANDRUFF- zinc pyrithione shampoo

  • 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 September 22, 2023

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  • ACTIVE INGREDIENT

    Zinc Pyrithione 1%

  • PURPOSE

    Anti-Dandruff

  • INDICATIONS & USAGE

    For the relief of the symptoms of dandruff.

  • WARNINGS

    For external use only.

    Do not use on wounds or damaged skin or on a child under 12 years of age unless directed by a physician.

  • WHEN USING

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Conditions 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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Apply a small amount quantity of the product into hair and massage the scalp.
    Rinse thoroughly with enough water, repeat if needed.

    For best results, use at least twice a week or as directed by a doctor.

  • OTHER SAFETY INFORMATION

    See on the bottom of the bottle for lot number and expiration date.

  • INACTIVE INGREDIENT

    Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Acrylates Copolymer, Cocamide MEA, Cocamidopropylamine Oxide, Caprylyl Glycol, Hexylene Glycol, Fragrance (Parfum), Polyquaternium-7, Sodium Hydroxide, Disodium EDTA, Citric Acid, Panthenol, Phenoxyethanol, FD&C Blue No.1 (CI 42090), Hexyl Cinnamal, Benzyl Salicylate, Coumarin, Alpha-Isomethyl Ionone, Geraniol, Linalool.

  • QUESTIONS

    QUESTION OR COMMENTS?

    Call (305)-900-8256

  • DZUL ANTI-DANDRUFF SHAMPOO

    DZUL ANTIDANDRUFF SHAMPOO

  • INGREDIENTS AND APPEARANCE
    DZUL ANTI-DANDRUFF 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83037-001
    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
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    COUMARIN (UNII: A4VZ22K1WT)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GERANIOL (UNII: L837108USY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83037-001-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03209/22/2023
    Labeler - Caball Sales, Inc. (047422138)
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