Label: MEDPRIDE EN SHIELD ALOE SOFT VITAMIN ENRICHED- zinc oxide cream 

  • NDC Code(s): 52410-3060-2, 52410-3060-3, 52410-3060-4, 52410-3060-5
  • Packager: Shield Line LLC
  • 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 06/13

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

  • Active Ingredient

    Zinc Oxide (1.8%w/w)

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  • Purpose

    Skin Protectant

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  • Uses

    ■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns 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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  • When using this product

    ■ do not get into eyes

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  • Stop Use and ask a doctor if

    if conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

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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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  • Directions

    ■ 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 needed

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  • Other Information

    ■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

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  • Inactive ingredients

    aloe vera leaf, alpha-tocopherol, aeteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender
    methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium
    steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

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  • Package Label
  • INGREDIENTS AND APPEARANCE
    MEDPRIDE  EN SHIELD ALOE SOFT VITAMIN ENRICHED
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52410-3060
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.8 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ALPHA-TOCOPHEROL  
    CETETH-10  
    CETOSTEARYL ALCOHOL  
    CETYL ACETATE  
    CHOLECALCIFEROL  
    GLYCERIN  
    LANOLIN  
    LAVENDER OIL  
    METHYLPARABEN  
    MINERAL OIL  
    PARAFFIN  
    PETROLATUM  
    PHENOXYETHANOL  
    POLYETHYLENE GLYCOL 6000  
    POLYSORBATE 60  
    PROPYLPARABEN SODIUM  
    STEARETH-20  
    TROLAMINE  
    VITAMIN A  
    WATER  
    FD&C YELLOW NO. 5  
    D&C RED NO. 21  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52410-3060-2 5 g in 1 PACKET
    2 NDC:52410-3060-3 15 g in 1 PACKET
    3 NDC:52410-3060-4 113 g in 1 TUBE
    4 NDC:52410-3060-5 453 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 05/27/2013
    Labeler - Shield Line LLC (078518916)
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