Label: DERMAZINC- pyrithione zinc cream

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

Drug Label Information

Updated November 24, 2023

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  • ACTIVE INGREDIENT

    Pyrithione Zinc 0.25%

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children.

  • PURPOSE

    Seborrheic Dermatitis treatment

  • DOSAGE & ADMINISTRATION

    Apply to affected area twice daily or as directed by a doctor.

  • INDICATIONS & USAGE

    For relief of the symptoms of seborrheic dermatitis.

  • 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 aloe barbadensis leaf (aloe vera gel) juice, carbomer, cetyl
    alcohol, dimethicone, DMDM hydantoin, glyceryl stearate, isopropyl palmitate, methylparaben,
    mineral oil, PEG-75 lanolin, sodium 1auryl sulfate, stearic acid, tocopheryl acetate (vitamin E),
    triethanolamine,undecylenic acid, water

  • PRINCIPAL DISPLAY PANEL

    DermaZinc Cream

  • INGREDIENTS AND APPEARANCE
    DERMAZINC 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35324-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35324-001-04114 g in 1 JAR; 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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