Label: DERMA GRAN GP - petrolatum ointment

  • NDC Code(s): 68599-6106-3
  • 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:

    Petrolatum,USP  85% W/W


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  • Purpose

    Skin Protectant


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  • Uses:

    • Helps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and lips.
    • For the temporary protection of minor cuts, scrapes burns and sunburns.
    • Helps treat and prevent minor skin irritations due to diaper rash and helps seal out wetness.
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  • 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.

    Keep out of reach of children


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  • Directions

    Cleanse area and dry thoroughly. Apply liberally, directly to the affected area as often as necessary.


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  • Other Ingredients:

    Allantoin, Aloe Vera Gel, Mineral oil (and) lanolin alcohol, Propylene glycol, Propylparaben.


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  • Customer Storage:

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


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  • Principal Display Panel

    MCKESSON

    DERMA GRAN GP
    GENERAL SKIN PROTECTANT
    NDC 68599-6106-3

    WITH ALOE VERA AND ALLANTOIN

    • Soothing Skin Emollients
    • Latex Free

    MFR # 61-S2054Z
    4
    FL OZ ( 113 g)

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  • INGREDIENTS AND APPEARANCE
    DERMA GRAN GP 
    petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-6106
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PETROLATUM (PETROLATUM) PETROLATUM 85 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    ALOE VERA LEAF  
    MINERAL OIL  
    LANOLIN ALCOHOLS  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-6106-3 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 11/12/2013
    Labeler - McKesson Medical-Surgical (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Derma Sciences Canada, Inc. 200564891 manufacture(68599-6106)
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