Label: DIAPERRASHOINTMENT- zinc oxide ointment

  • NDC Code(s): 68016-128-20
  • Packager: Pharmacy Value Alliance, LLC
  • 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 May 8, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 40%

  • Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin due to diaper rash and helps protect skin from wetness
  • Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Warnings

    For External Use Only

    When using this product

    • Avoid contact with eyes
  • Directions

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area and 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.
  • Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again with a few days
  • Other Information:

    • Store at controlled room temperature 20° - 25°C (68° - 77°F)
  • Inactive Ingredients

    BHA, Cod liver oil (high in vitamin A and D), Frangrance, Lanolin, Mineral Oil, Methylparaben, Petrolatum, Purified water, Talc, Tartrazine yellow #4 (FD and C yellow #4)

  • Helps treat and prevent diaper rash. Protects skin. Relieves Chafing. Promotes Healing

    Distributed by:

    Pharmacy Value Alliance, LLC.

    407 East Lancaster Avenue, Wayne, PA. 19087 USA

    www.emersongroup.com

  • Packaging

    Packaging

  • INGREDIENTS AND APPEARANCE
    DIAPERRASHOINTMENT 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-128-20113 g in 1 TUBE; Type 0: Not a Combination Product02/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/22/2016
    Labeler - Pharmacy Value Alliance, LLC (101668460)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
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