Label: PEDI-DERM BUM- zinc oxide paste

  • NDC Code(s): 69715-100-01
  • Packager: Elixir Solutions, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • Active Ingredient

    Zinc Oxide (CI 77947) 25%

  • Purpose

    Skin Protectant

  • Uses:

    Treats diaper rash and skin irritations

  • Warnings

    For external use only. Do not use in the eyes or if you allergic to any of the ingredients. Stop use and ask a doctor if you need to use longer than 1 week or condition worsens.

    Keep out of reach of children.

    If swallowed get medical help or contact Poison Control Center right away.

  • Directions:

    Apply a thick coat after diaper change, especially at bedtime. If baby cries during application it is because of their sensitive skin, this product does not sting. Use soft cloth or paper towel to clean bottom.

  • Other Information:

    Do not store in conditions of excess humidity or heat beyond 42°C (107°F).
    Do not use if seal under cap is missing or broken.

  • Inactive Ingredients:

    Bismuth Subgallate, Gossypium Herbaceum (Cotton) Seed Oil, Lanolin, Zea Mays (Corn) Starch.

  • Principal Display Panel - Carton Label

    Letourneau’s Pharmacy

    Pedi-Derm Bum Paste™

    Compounding Prescriptions Since 1926

    Net WT
    4oz (120g)

    Carton Label
  • INGREDIENTS AND APPEARANCE
    PEDI-DERM BUM 
    zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69715-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BISMUTH SUBGALLATE (UNII: YIW503MI7V)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69715-100-01120 g in 1 JAR; Type 0: Not a Combination Product10/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/05/2015
    Labeler - Elixir Solutions, Inc. (070917614)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(69715-100)
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