Label: DERMAMED- skin protectant 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 January 17, 2020

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  • ​Active ingredient

    Aluminum Hydroxide Gel 2%

  • Purpose

    Skin protectant

  • Uses

    Dries the oozing and weeping of poison: ivy, oak, or sumac, or other skin irritations.

  • Warnings

    For external use only.

    Avoid contact with eyes. In case of contact, flush thoroughly with water.

  • Warnings

    Stop 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 of accidental ingestion contact a Physician or Poison Control Center right away.

  • Directions

    Apply liberally to the affected area as needed or as directed by a physician.

  • Other information

    • Store at room temperature (59º- 86ºF)
    • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.
  • Inactive ingredients

    Petrolatum, Lanolin, Water, Propylene Glycol, Stearyl Alcohol, Calcium Carbonate, Magnesium Hydroxide, Zinc Chloride, DMDM Hydantoin, Methylparaben, Propylparaben, Sodium Laureth Sulfate, Lanolin Alcohol, Cholecalciferol, Zea Mays (Corn) Oil, Retinyl Palmitate, Citric Acid, Sodium Chloride

  • Questions?

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

  • DermaMed Package Label and Principal Display Panel

    Package LabelCase Label

  • INGREDIENTS AND APPEARANCE
    DERMAMED 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-214
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CORN OIL (UNII: 8470G57WFM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-214-04106 g in 1 TUBE; Type 0: Not a Combination Product10/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/18/2016
    Labeler - DermaRite Industries, LLC (883925562)
    Registrant - DermaRite Industries, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DermaRite Industries, LLC883925562manufacture(61924-214)
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