Label: DERMACEN SKIN PROTECTANT- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 January 28, 2023

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  • Active ingredient

    Zinc Oxide 5.0%

  • Purpose

    Anorectal

  • Uses

    Provides temporary relief of itching and discomfort in the perineal area

  • Warnings

    For External Use Only.

    • If condition worsens or does not improve within 7 days, consult a physician
    • Do not exceed the recommended daily dosage unless directed by a physician
    • In case of bleeding, consult a physician immediately
  • Directions

    When practical, clean the affected area by patting or blotting with an appropriate cleaning pad.

    Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

    Apply Skin Protectant Cream externally to affected area

  • Inactive ingredients

    Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol (Vitamin D3), Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, DMDM Hydantoin, Ethylhexyl Palmitate, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Iodopropynyl Butylcarbamate, Isopropyl palmitate, Polyglyceryl-4 Isostearate, Putified Water, Retinyl Palmitate (Vitamin A), Sodium Chloride, Tocopherol (Vitamin E), Zea Mays Oil

  • Questions?

    Call 800-255-0262

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Skin

    Protectant

    Cream

    Conains Zinc

    Oxide with

    Vitamins A,D, and E

    Net Contents:

    6 fl oz (177.4 mL)

    DCSPC label DCSPC label

  • INGREDIENTS AND APPEARANCE
    DERMACEN SKIN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-148-06177.4 mL in 1 TUBE; Type 0: Not a Combination Product12/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34612/06/2019
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-148)
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