Label: DANDRUFF- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2023

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  • Active ingredient

    Pyrithione zinc 0.3%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only.

    When using this product do not get into 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 as directed.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Posion Control Center right away.

  • Directions

    • shake well • for maximum dandruff control, use every time you shampoo • wet hair, massage onto scalp, rinse, repeat if desired • for best results, use at least twice a week or as directed by a doctor

  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80801-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80801-103-01355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03205/01/2023
    Labeler - Primal Elements (968334144)
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