Label: DIAPER RASH SKIN PROTECTANT- lanolin and petrolatum ointment

  • NDC Code(s): 52000-073-03, 52000-073-04
  • Packager: Universal Distribution Centre LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lanolin 15.5%Diaper rash ointment
    Petrolatum 53.4%Skin Protectant
  • Uses

    • helps treat and prevent diaper rash
    • temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
    • protect chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

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

  • Directions

    • for skin protectant useapply as needed
    • for diaper rash use:
      • 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
  • Other information

    store between 20°C to 25 °C (68° to 77°F)

  • Inactive Ingredients

    cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

  • PRINCIPAL DISPLAY PANEL - 35.4g Carton

    Label

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH SKIN PROTECTANT 
    lanolin and petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN136.4 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM469.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    Colororange (Unctuous amber mass) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-073-031 in 1 CARTON01/25/2021
    1NDC:52000-073-0435.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/25/2021
    Labeler - Universal Distribution Centre LLC (019180459)
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