Label: LINCOSHIELD- 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 October 5, 2016

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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
    • 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 or 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 as often as necessary or with each diaper change, especially at bedtime or any time 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, Tocopherol Acetate (Vitamin E), Water, White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    LINCOSHIELD 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-8020
    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
    CORN OIL (UNII: 8470G57WFM)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69636-8020-4452 g in 1 JAR; Type 0: Not a Combination Product10/06/2016
    2NDC:69636-8020-0100 g in 1 TUBE; Type 0: Not a Combination Product10/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/06/2016
    Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-8020)
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