Label: MEDPRIDE EN SHIELD- zinc oxide dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 3, 2013

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  • Active Ingredient

    Zinc Oxide (1.8%w/w)

    Dimethicone 1.8%

  • Purpose

    Skin Protectant

    Skin Protectant

  • Uses

    ■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

  • Warnings

    For external use only

  • When using this product

    ■ do not get into eyes

  • Stop Use and ask a doctor if

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

  • 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.

  • 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

  • Other Information

    ■ do not use if seal is punctured or not visible ■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

  • 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

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE  EN SHIELD
    zinc oxide dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-3065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.8 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VITAMIN A (UNII: 81G40H8B0T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-3065-4113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/27/2013
    Labeler - Shield Line LLC (078518916)
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