Label: BPCO OINTMENT-

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated September 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Wound Dressing
    Rx Only

  • DESCRIPTION

    DESCRIPTION: BPCO Ointment contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

  • SPL UNCLASSIFIED SECTION

    ACTION: BPCO Ointment provides a moist wound environment and acts as a protective wound covering.

  • INDICATIONS & USAGE

    INDICATIONS: BPCO Ointment is a wound dressing for topical use used to manage chronic and acute wounds, and dermal ulcers.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS: BPCO Ointment is contraindicated in persons who have shown hypersensitivity to Balsam Peru, Petrolatum or any of the other ingredients used in this ointment.

  • SPL UNCLASSIFIED SECTION

    USES: BPCO Ointment is easy to apply. The wound may be left open or appropriate dressing applied. Please note that wounds generally heal poorly in the presence of hemoglobin or zinc deficiency.

  • WARNINGS

    WARNING: FOR EXTERNAL USE ONLY: Do not apply to fresh arterial clots. Avoid contact with eyes. Keep tightly closed. Use only as directed by a physician. When applied to a sensitive area, a temporary stinging may occur. Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    USUAL DOSAGE: Apply a thin film of BPCO Ointment topically a minimum of twice daily or as often as necessary. Wound may be left unbandaged or appropriate dressing can be applied. To remove, wash gently with an appropriate wound cleanser.

  • HOW SUPPLIED

    HOW SUPPLIED: BPCO Ointment is supplied as follows:

    5 gram tube
    20 per carton    		50268-999-20

    STORAGE: Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however such exposure should be minimized. See USP Controlled Room Temperature. Protect from freezing.

    See carton and crimp for lot number and expiration date.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478
    Toll Free: 1.855.361.3993

    AV 10/19

  • PRINCIPAL DISPLAY PANEL - 20 Tube Carton

    Product Code 50268-999-20 Rx only

    BPCO Ointment

    Wound Dressing

    20 Tubes

    PRINCIPAL DISPLAY PANEL - 20 Tube Carton
  • INGREDIENTS AND APPEARANCE
    BPCO OINTMENT 
    dressing, wound, occlusive
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:50268-999
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:50268-999-2020 in 1 CARTON
    15 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceNAD04/15/2020
    Labeler - AVPAK (832926666)
    Establishment
    NameAddressID/FEIBusiness Operations
    AvPAK832926666label
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