Label: DERMASEPTIN- otc skin protectant drug products ointment

  • 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 September 13, 2018

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  • Active Ingredients

    • Zinc Oxide 19%
    • Calamine 2%
  • Purpose:

    • Zinc Oxide: Skin protectant
    • Calamine : Skin protectant
  • Uses:

    Dries the oozing and weeping of poison:

    • Ivy
    • Oak
    • Sumac
    • Or othe skin irritations
  • Warnings

    • For external use only.
    • Avoid contact with eyes. In case of contact, flush thoroughly with water.
    • Stop use and ask a doctor if condition worsens
    • Symptoms last more than 7 days or clear up and occur again within a few days.
  • Warnings:

    • Keep out of reach of children. In case accidental ingestion contact a physician or Poison Control Center right away.
  • Directions


    Applied as needed.

  • Other Information:

    Store at room temperature (59°-86°F).

    You may report a serious adverse event to DermaRite Industires, PO Box 7209, North Bergen, NJ 07047.

  • Inactive Ingredients:

    Petrolatum, Lanolin, Glycerin, Menthol, Sodium Bicarbonate, methylparaben, Propylparaben

  • Questions

    Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

  • Dermaseptin Package Label Principal Display Panel

    DermaSeptin

  • INGREDIENTS AND APPEARANCE
    DERMASEPTIN 
    otc skin protectant drug products ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED2.3 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21.47 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-210-055 g in 1 PACKET; Type 0: Not a Combination Product10/25/2010
    2NDC:61924-210-04113 g in 1 TUBE; Type 0: Not a Combination Product10/25/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/25/2010
    Labeler - DermaRite Industries, LLC (883925562)
    Registrant - DermaRite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite Industries, LLC883925562manufacture(61924-210)
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