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 August 28, 2017

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  • 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 Item Code (Source) NDC:54162-221
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 1.356 g  in 113 g
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54162-221-01 113 g in 1 TUBE; Type 0: Not a Combination Product 07/31/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 07/31/2015
    Labeler - GERITREX LLC (112796248)
    Registrant - GERITREX LLC (112796248)
    Establishment
    Name Address ID/FEI Business Operations
    GERITREX LLC 112796248 manufacture(54162-221)
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