Label: DERMAZINC- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 24, 2023

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 2%

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

  • PURPOSE

    Anti-dandruff

    Seborrheic Dermatitis treatment

  • DOSAGE & ADMINISTRATION


    Apply to wet hair and massage into hair and scalp; rinse thoroughly

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

  • INDICATIONS & USAGE

    For relief of the symptoms of seborrheic dermatitis and dandruff.

  • WARNINGS

    Warnings
    ■ For external use only.
    ■ Ask a doctor before use if you have a condition that covers a large area of the body.

    When using this product avoid contact with the 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.

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Inactive ingredients
    ammonium laureth sulfate, ammonium lauryl sulfate, citric acid, cocamide DEA, cocamidopropyl
    betaine, DMDM hydantoin, isopropyl alcohol, menthol, titanium dioxide, water, FD&C blue #2,
    FD&C yellow #5

  • PRINCIPAL DISPLAY PANEL

    DermaZinc Shampoo

  • INGREDIENTS AND APPEARANCE
    DERMAZINC 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35324-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    MENTHOL (UNII: L7T10EIP3A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35324-003-08240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03208/29/2022
    Labeler - WynnPharm Inc (620885173)
    Registrant - WynnPharm Inc (620885173)
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