Label: SHIELD AND PROTECT BARRIER CREAM- petroleum, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 8, 2024

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  • Active Ingredients

    Zinc Oxide

    Petrolatum

  • Keep out of rach of children

    Keep out of reach of Children

  • Inactive Ingredients

    Purified water

    Mineral Oil

    Sodium Chloride

    Hydrogenated Castor Wax

    Beeswax

    Imidazolidinyl Urea

    Paraffin

    Propylparaben

    Methylparaben

    Vitamin A Palmitate

    Cetostearyl alcohol

    Vitamin D

    Vitamin E(alpha tocopherol)

  • Purpose

    Gentell Shield & Protect Moisture Barrier Cream forms a water-shedding shield thta helps soothe and protect dry or irritated skin. Theraprutic against irritation from urine, feces, and other bodily secretions. Sheild & Protect leaves skin soft and smooth rather than irretated and greasy. Ideal for sensitive skin.

  • Warnings

    For external use only

    Avoid eye contact

    Discontinue use and contact a physiciean if condition worsens, or symptoms persist from more than seven days

    Keep this out of the reah of children

  • Dosage & Administration

    Carefully cleanse the area and pat dry thoroughly. Apply liberally to desired areas as often as necessary or when prolonged wxposure is anticipated.

  • Indication and usage

    Shield & Protect Moisture Barrier Cream helps restore, replenish and soothe ry irritated or otherwise compromised skin.

    It helps treat or pevent minor skin irritations assoiated with incontinence.

    Protects fom and seals out wetness

  • Primary Label

    4oz

    Shield and Protect Shield and Protect Ointment

  • INGREDIENTS AND APPEARANCE
    SHIELD AND PROTECT BARRIER CREAM 
    petroleum, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61554-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.13 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM10.32 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41) 0.05 g  in 100 g
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.03 g  in 100 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.48 g  in 100 g
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.36 g  in 100 g
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 20.64 g  in 100 g
    WATER (UNII: 059QF0KO0R) 59.52 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.1 g  in 100 g
    IMIDUREA (UNII: M629807ATL) 0.3 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.25 g  in 100 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 3.44 g  in 100 g
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) 0.36 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61554-500-01118 g in 1 TUBE; Type 0: Not a Combination Product11/13/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/13/2014
    Labeler - Gentell LLC (170967876)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gentell LLC170967876manufacture(61554-500)
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