Label: DYNASHIELD WITH DIMETHICONE- zinc oxide and dimethicone cream

  • NDC Code(s): 67777-228-01, 67777-228-02
  • Packager: Dynarex Corporation
  • 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 05/14

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  • ACTIVE INGREDIENT

    Active ingredient        Purpose
    Zinc Oxide (200 mg)      Diaper Rash
    Dimethicone 1.8%         Skin Protectant

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  • Uses:

    • Helps treat and prevent diaper rash.
    • Dries the oozing and weeping of
    • poison ivy
    • poison oak
    • poison sumac

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  • Warnings:

    For external use only

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  • Directions:

    For diaper rash

    • change wet and soiled diapers promptly
    • cleanse the diaper area and allow to dry
    • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    For poison ivy, oak and sumac

    • apply ointment liberally as often as needed
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  • Other information

    • Do not use if seal is punctured or not visible
    • store at room temperature 15°-30° C (59°-86° F)
    • avoid excessive heat
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  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

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  • Stop use if

    • conditions worsen
    • symptoms last more than 7 days or clear up and occur in a few days, consult a physician
    • over large areas of the body
    • if you are allergic to these ingredients
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  • Indications and Usage

    Indications are for diaper rash and general skin protectant.

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  • Do not use

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • Keep out of reach of children

    • Keep out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center right away.
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  • Principal Display Panel

    Dynashield with Dimethicone

    Dynashield



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  • INGREDIENTS AND APPEARANCE
    DYNASHIELD  WITH DIMETHICONE
    zinc oxide and dimethicone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67777-228
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg  in 1 g
    DIMETHICONE (DIMETHICONE) DIMETHICONE 18 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    CETYL ALCOHOL  
    CHOLECALCIFEROL  
    LANOLIN  
    METHYLPARABEN  
    MINERAL OIL  
    PETROLATUM  
    WATER  
    CETETH-10  
    PARAFFIN  
    PROPYLPARABEN SODIUM  
    GLYCERIN  
    PHENOXYETHANOL  
    STEARETH-20  
    POLYETHYLENE GLYCOL 6000  
    POLYSORBATE 60  
    CETOSTEARYL ALCOHOL  
    VITAMIN A  
    ALPHA-TOCOPHEROL  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67777-228-01 24 in 1 CARTON
    1 113.4 g in 1 TUBE
    2 NDC:67777-228-02 144 in 1 BOX
    2 5 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 09/01/2009
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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