Label: DR SMITHS DIAPER- zinc oxide ointment

  • NDC Code(s): 0178-0330-02, 0178-0330-03, 0178-0330-08
  • Packager: Mission Pharmacal
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

    Zinc Oxide 10%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product,avoid contact with the eyes.

  • STOP USE

    See a doctorif condition lasts more than 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • change wet and soiled diapers promptly
    • cleanse the diaper area
    • allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Storage and Handling

    Store between 15 0and 30 0C (59 0and 86 0F)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

  • OTHER SAFETY INFORMATION

    To reporta serious adverse event of obtain product information, call (201)-696-8400

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DR SMITHS DIAPER 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    THYMOL IODIDE (UNII: A51HJM3XSU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0178-0330-0385 g in 1 TUBE; Type 0: Not a Combination Product10/05/2023
    2NDC:0178-0330-0256.7 g in 1 JAR; Type 0: Not a Combination Product03/01/201010/05/2023
    3NDC:0178-0330-08226.8 g in 1 JAR; Type 0: Not a Combination Product03/01/201010/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01603/01/2010
    Labeler - Mission Pharmacal (008117095)
    Registrant - Mission Pharmacal (008117095)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mission Pharmacal Company927726893analysis(0178-0330) , manufacture(0178-0330) , label(0178-0330) , pack(0178-0330)