Label: DERMACEN PROTECTANT- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 December 6, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc oxide 5.0%

  • PURPOSE

    Purpose

    Anorectal Cream

  • INDICATIONS & USAGE

    Uses

    Provides temporary relief of itching and discomfort in the perineal area

  • WARNINGS

    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 promptly

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    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 DermaCen Protectant Cream externally to the affected area.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Cyclotetrasiloxane, Cyclopentasiloxane, Mineral Oil, Isopropyl Palmitate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Ethylhexyl Palmitate, Glycerin, Cetyl Dimethicone, Dimethicone, Tocopherol, Zea Mays Oil, Retinyl Palmitate, Cholecalciferol, Beeswax, Hydrogenated Castor Oil, Sodium Chloride, Diazolidinyl Urea, Methyl Paraben

  • PRINCIPAL DISPLAY PANEL

    DermaCen

    Protectant Cream

    A medicated

    moisturizing cream

    for prevention and

    protection of skin

    irritations

    Net Contents 6 ounces (170g)

    container label

  • INGREDIENTS AND APPEARANCE
    DERMACEN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62654-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    QUADROSILAN (UNII: C5KT601WPM)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62654-313-06170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/2001
    Labeler - Central Solutions Inc (007118524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions Inc007118524manufacture(62654-313)
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