Label: DERMADROX- aluminum hydroxide ointment 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredients Purpose

    Aluminum Hydroxide 1.2% A Skin protectant

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  • 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

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  • Directions

    Apply liberally as often as necessary to minor burns, abraded skin,

    irritated areas and minor wounds.

    Reapply at least every 12 hours.

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  • 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.

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  • Inactive Ingredients

    Calcium Carbonate, Citric acid, Deionized water, Glycerin, Lanolin, Lanolin Alcohol,

    Mangnesium hydroxide, Methyl and propyl parabens, Mineral oil, Petrolatum,

    Sodium chloride, Sodium laureth sulfate, Stearyl alcohol, Vitamin A and D in a

    Hydrophilic ointment base, Zinc chloride.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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  • STORAGE AND HANDLING

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

    Keep lid tightly closed.

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  • DOSAGE & ADMINISTRATION

    Reapply at least every 12 hours

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  • INGREDIENTS AND APPEARANCE
    DERMADROX 
    aluminum hydroxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54162-221
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 1.2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    CITRIC ACID ACETATE  
    WATER  
    GLYCERIN  
    LANOLIN  
    LANOLIN ALCOHOLS  
    MAGNESIUM HYDROXIDE  
    METHYLPARABEN  
    PROPYLPARABEN  
    MINERAL OIL  
    PETROLATUM  
    SODIUM CHLORIDE  
    SODIUM LAURETH SULFATE  
    STEARYL ALCOHOL  
    VITAMIN A  
    VITAMIN D  
    ZINC CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54162-221-01 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part346 01/30/2013
    Labeler - GERITREX CORP (112796248)
    Registrant - GERITREX CORP (112796248)
    Establishment
    Name Address ID/FEI Business Operations
    GERITREX CORP 112796248 manufacture(54162-221)
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