Label: DR SMITHS DIAPER- 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 February 24, 2020

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  • 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 doctor if 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 0 and 30 0 C (59 0 and 86 0 F)

  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • OTHER SAFETY INFORMATION

    To report a serious adverse event of obtain product information, call (502)709-7544.

  • PRINCIPAL DISPLAY PANEL

    3 oz. Carton

  • INGREDIENTS AND APPEARANCE
    DR SMITHS DIAPER 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71269-006
    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:71269-006-0385 g in 1 TUBE; Type 0: Not a Combination Product01/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/19/2018
    Labeler - MainPointe Pharmaceuticals, LLC (080544378)
    Registrant - Mission Pharmacal (927726893)
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