Label: DERMA GRAN- aluminium 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 June 16, 2015

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  • Active Ingredients:

    Aluminium Hydroxide Gel  0.275%


  • Purpose

    Skin Protectant


  • Uses:

    • Dries the oozing, and weeping of poison ivy, poison oak, or poison sumac.
    • For the temporary protection, comfort and lubrication of minor skin irritations such as intertrigo, chafing, galling, rubbing or friction.
  • Warnings:

    For external use only.

    Avoid contact with eyes.

    Not to be applied over deep or puncture wounds, infections or  lacerations. Consult a physician.

    If condition worsens or does not improve within 7 days stop use and consult a physician.

    Do not use on

    children under 6 months of age without consulting a physician.


    Keep this and all medicines out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    Cleanse area and dry thoroughly. Apply as needed, directly to the affected area.


  • Other Ingredients:

    Calcium carbonate, Lanolin, Magnesium hydroxide, Methlyparaben, Petrolatum, Propylene glycol, Propylparaben, Sodium Chloride, Sodium Lauryl Sulfate, Stearyl alcohol, Vitamin A Palmitate, Water, Zinc Chloride.


  • Customer Storage:

    Store at a Controlled Room Temperature 15-30o(59-86oF)


  • Principal Display Panel

    DERMA GRAN

    OINTMENT

    NDC 64772-126-36

    • pH Balanced
    • Skin Protectant
    • Latex Free

    4 FL OZ (113 g)

    Untitled.jpg


    DERMA GRAN

    OINTMENT

    NDC 64771-126-34



    • pH Balanced
    • Skin Protectant
    • Latex Free

    gdtyulktlteled.jpg

  • INGREDIENTS AND APPEARANCE
    DERMA GRAN  
    aluminium hydroxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64772-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALGELDRATE (UNII: 03J11K103C) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALGELDRATE0.275 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64772-126-36113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:64772-126-34113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/16/2015
    Labeler - Derma Sciences Canada, Inc. (200564891)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Sciences Canada, Inc.200564891manufacture(64772-126)
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