Label: DERMA GRAN BC PERINEAL PROTECTANT- zinc oxide and petrolatum ointment 

  • Label RSS
  • NDC Code(s): 68599-6105-3
  • 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:

    Zinc Oxide 20% Petrolatum 30%


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  • Purpose

    Protectant


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  • Uses:

    • Helps seal out wetness and protects against minor skin irritations due to moisture, urine, feces, and perspiration. Also helps prevent and temporarily protect chafed, chapped or cracked skin.
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  • Warnings:

    For external use only.

    Avoid contact with eyes.

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


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  • Directions

    • Cleanse affected area with Stay Dry Perineal Cleanser and lightly pat dry.
    • Apply an even fine film of DermaGran BC Perineal Protectant to the area.
    • Cleanse skin after each incontinent episode.
    • Reapply DermaGran BC Perineal Protectant as necessary.

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  • Other Ingredients:

    Bentonite, Dimethiconol/Cyclomethicone, Laurylmethicone copolyol, Magnesium sulfate, Methylparaben, Propylparaben, Sodium chloride, Sorbitan tristearate, Steareth -20, Vitamin A palmitate, Water.


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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 BC
    PERINEAL PROTECTANT
    NDC 68599-6105-3

    WITH ZINC PLUS VITAMIN A, BENTONITE AND DIMETHICONE


    • pH Balanced
    • Latex Free

    MFR # 61-ND35
    3.5
    FL OZ ( 98 g)

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  • INGREDIENTS AND APPEARANCE
    DERMA GRAN BC  PERINEAL PROTECTANT
    zinc oxide, petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68599-6105
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 g  in 100 g
    PETROLATUM (PETROLATUM) PETROLATUM 30 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    BENTONITE  
    CYCLOMETHICONE  
    MAGNESIUM SULFATE  
    METHYLPARABEN  
    PROPYLPARABEN  
    SODIUM CHLORIDE  
    SORBITAN TRISTEARATE  
    STEARETH-20  
    VITAMIN A PALMITATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68599-6105-3 98 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/12/2013
    Labeler - McKesson Medical-Surgical (023904428)
    Establishment
    Name Address ID/FEI Business Operations
    Derma Sciences Canada, Inc. 200564891 manufacture(68599-6105)
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