Label: DERMADROX- aluminum hydroxide 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 October 20, 2016

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  • Drug Facts

    Active Ingredients                    Purpose

    Aluminum Hydroxide Gel         A skin protectant

  • Intended Use

    Used for relief of minor skin irritations such as chafing, Interigo and galling

    Provides temporary relief to abraded skin, friction burns and rubbing

    Lubricates effectively on psoriatic skin

    Effective for dried cracked skin, sunburn and abraded skin

  • Warnings

    For External Use Only

    Avoid contact with eyes

    Discontinue use if symptoms persist for more than 7 days

    DERMADROX ointment is contraindicated in patients with a history of hypersensitivity to any of its components

  • Inactive Ingredients

    Calcium Carbonate, Citric Acid, Deionized Water, Glycerin, Lanolin, Lanolin Alcohol, Magnesium Hydroxide, Mineral Oil,

    Petrolatum, Sodium Chloride, Sodium Laureth Sulfate, Stearyl Alcohol, Vitamin A and D, Zinc Chloride

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Storage

    Store at room temperature (59'F-86'F) Keep lid tightly closed

  • DOSAGE & ADMINISTRATION

    Reapply at least every 12 hours

  • Direction

    Apply liberally as often as necessary to minor burns, abraded skin, irritated areas and minor wounds

    Reapply at least every 12 hours

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DERMADROX 
    aluminum hydroxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE1.356 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    VITAMIN A (UNII: 81G40H8B0T)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-221-04113 g in 1 JAR; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/15/2013
    Labeler - GERITREX LLC (112796248)
    Registrant - GERITREX LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX LLC112796248manufacture(54162-221)
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