Label: DABUR ZINC OXIDE 3.8%- zinc oxide ointment

  • NDC Code(s): 68747-8020-0, 68747-8020-4
  • Packager: Dabur India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 20, 2024

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  • Active Ingredient

    Zinc Oxide 3.8%

  • Purpose

    Skin Protectant

  • Uses

    ■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ 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 as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

  • Inactive ingredients

    Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

  • Package Label

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    DABUR  ZINC OXIDE 3.8%
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68747-8020
    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
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    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)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68747-8020-4452 g in 1 JAR; Type 0: Not a Combination Product01/01/2015
    2NDC:68747-8020-0100 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 DrugM01601/01/2015
    Labeler - Dabur India Limited (650319218)
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