Label: BALSAM PERU AND CASTOR OIL- ointment

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

Drug Label Information

Updated January 15, 2019

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  • SPL UNCLASSIFIED SECTION

    NDC 75834-139-60

    Rx Only

    Wound Dressing

  • DESCRIPTION

    Balsam Peru & Castor Oil Ointment contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

  • ACTION

    Balsam Peru & Castor Oil Ointment helps to deodorize and protectively cover pressure wounds (ulcers) and may help with the reduction of pain. Balsam Peru & Castor Oil Ointment provides a moist wound environment conductive to healing. The moisturizing properties of Balsam Peru & Castor Oil Ointment also help in the prevention of cracking around the edges of sores.

  • INDICATIONS

    Balsam Peru & Castor Oil Ointment is a wound dressing for topical use in the management of chronic and acute wounds, and dermal ulcers including: pressure ulcers (Stage I-IV), venous stasis ulcers, diabetic ulcers, first and second degree burns, surgical wounds, traumatic wounds, superficial wounds, ulcers resulting from arterial insufficiency and grafted wound/donor sites.

  • CONTRAINDICATIONS

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

  • USES

    Balsam Peru & Castor Oil Ointment is easy to apply and quickly reduces odors frequently accompanying a decubitus ulcer. 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.

  • WARNING

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

  • USUAL DOSAGE

    Apply a thin film of Balsam Peru & Castor Oil 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

    Balsam Peru & Castor Oil Ointment is supplied as follows:

    SIZENDC NUMBER
    60 GRAM TUBE75834-139-60

    STORAGE

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). 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 crimp for lot number and expiration date.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Nivagen Pharmaceuticals, Inc.
    Sacramento, CA 95827 USA
    Toll free number: 1-877-977-0687

    Rev. 07/18

  • PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton

    NDC 75834-139-60
    Rx only

    Balsam Peru
    & Castor Oil
    Ointment

    NIVAGEN
    PHARMACEUTICALS

    Wound Dressing

    Net Wt. 60 grams

    PRINCIPAL DISPLAY PANEL - 60 gram Tube Carton
  • INGREDIENTS AND APPEARANCE
    BALSAM PERU AND CASTOR OIL 
    dressing, wound and burn, occlusive ointment
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:75834-139
    Route of AdministrationTOPICAL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:75834-139-601 in 1 CARTON
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceNAD12/14/2018
    Labeler - Nivagen Pharmaceuticals LLC (052032418)
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