Label: SMARTH PERISHIELD- zinc oxide ointment

  • 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 November 20, 2018

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  • Active Ingredient

    Zinc Oxide 3.8%

  • Purpose

    Skin Protectant

  • Uses

    ■ Helps treat and prevent diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash an ■ Helps protect skin from exposure to wetness

  • Warnings

    For external use only

  • When using this product

    ■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

  • Stop Use and ask a doctor if

    ■ condition worsens or doesn't improve within seven days

  • 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 ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

  • Inactive ingredients

    Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopheryl Acetate (Vitamin E) Water, White Petrolatum

  • Package Label

    Principal Display

  • INGREDIENTS AND APPEARANCE
    SMARTH  PERISHIELD
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71486-8020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71486-8020-4452 g in 1 JAR; Type 0: Not a Combination Product01/01/2015
    2NDC:71486-8020-0100 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2015
    Labeler - Glint cosmetics Private Limited (675910492)
    Establishment
    NameAddressID/FEIBusiness Operations
    GLINT COSMETICS PRIVATE LIMITED675910492manufacture(71486-8020)
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