Label: DERMA GRAN  - aluminum hydroxide ointment 

  • Label RSS
  • NDC Code(s): 68599-6103-3
  • Packager: McKesson Medical-Surgical
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 11/13

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

  • Active Ingredients:

    Aluminium Hydroxide Gel  0.275%


    Close
  • Purpose

    Skin Protectant


    Close
  • 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.
    Close
  • 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.


    Close
  • Directions

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


    Close
  • 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.


    Close
  • Customer Storage:

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


    Close
  • Principal Display Panel

    MCKESSON

    DERMA GRAN
    OINTMENT
    NDC 68599-6103-3



    • pH Balanced
    • Skin Protectant
    • Latex Free

    MFR # 61-DT4
    4
    FL OZ ( 113 g)


    Untitled.jpg

    Close
  • INGREDIENTS AND APPEARANCE
    DERMA GRAN  
    aluminium hydroxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-6103
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALUMINUM HYDROXIDE (ALUMINUM HYDROXIDE) ALUMINUM HYDROXIDE 0.275 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM CARBONATE  
    LANOLIN  
    MAGNESIUM HYDROXIDE  
    METHYLPARABEN  
    PETROLATUM  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM CHLORIDE  
    SODIUM LAURYL SULFATE  
    STEARYL ALCOHOL  
    VITAMIN A PALMITATE  
    WATER  
    ZINC CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-6103-3 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 11/12/2013
    Labeler - McKesson Medical-Surgical (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Derma Sciences Canada, Inc. 200564891 manufacture(68599-6103)
    Close