Label: BARRIER BALM- skin protectant ointment

  • NDC Code(s): 75523-200-02
  • Packager: PROJECT CHEMISTRY, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 15%

  • PURPOSE

    Skin Protectant

  • WARNINGS

    Warnings:

    For external use only.

  • WHEN USING

    When using this product, avoid wounds and contact with eyes.

  • STOP USE

    Stop use and ask a doctor if condition worsens or doesn't improve

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions:

    Apply a thin layer as needed to clean, dry skin.

  • INACTIVE INGREDIENT

    Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

  • INDICATIONS & USAGE

    To help prevent and relieve skin irritation from wetness.

  • PRINCIPAL DISPLAY PANEL

    ILBB2

  • INGREDIENTS AND APPEARANCE
    BARRIER BALM 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75523-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    C15-23 ALKANE (UNII: J3N6X3YK96)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    MENTHOL (UNII: L7T10EIP3A)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75523-200-0257 g in 1 TUBE; Type 0: Not a Combination Product10/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/19/2022
    Labeler - PROJECT CHEMISTRY, INC. (117491807)
    Establishment
    NameAddressID/FEIBusiness Operations
    Packaging On Demand, Inc.610511326manufacture(75523-200)
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