Label: DERMAZINC- pyrithione zinc soap

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

Drug Label Information

Updated June 6, 2024

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 2%

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

  • PURPOSE

    Dandruff, Seborrheic Dermatitis treatment

  • DOSAGE & ADMINISTRATION


    -Use on affected areas in place of regular soap.

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

    -Work up a rich lather using warm water and massage gently into affected areas.

    -Rinse well.

  • INDICATIONS & USAGE

    Controls, reduces and helps stop the symptoms of dandruff and seborrheic dermatitis.

  • WARNINGS

    Warnings

    ■ 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.

    ■ For external use only.

  • INACTIVE INGREDIENT

    Sodium Palmate, Sodium Cocoate, Water, Glycerin, Avena Sativa (Oat Kernel) Flour, Sodium Chloride, Grape Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyrospermum Parkii (Shea Butter), Theobroma Cacao (Cocoa) Seed Butter, Tetrasodium Glutamate Diacetate, Natural Vitamin E, Pentasodium Pentatate.

  • PRINCIPAL DISPLAY PANEL

    DermaZinc Soap

  • INGREDIENTS AND APPEARANCE
    DERMAZINC 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35324-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    WATER (UNII: 059QF0KO0R)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35324-004-04120 g in 1 BOX; Type 0: Not a Combination Product03/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/01/2024
    Labeler - WynnPharm Inc (620885173)
    Registrant - WynnPharm Inc (620885173)
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