Label: VASOLEX- trypsin, castor oil and balsam peru ointment

  • NDC Code(s): 58980-790-11, 58980-790-21, 58980-790-50
  • Packager: Stratus Pharmacuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 07/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    Each gram of VASOLEX™ OINTMENT contains: ACTIVES: Trypsin USP NLT 90 USP units, Balsam Peru 87.0mg and Castor Oil USP 788.0mg in an ointment base of: INACTIVES: Glyceryl Monostearate, Glycine, L-Proline, Taurine and White Petrolatum.

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  • ACTION

    Trypsin promotes debridement of eschar and other necrotic tissue. It appears that in many instances, removal of wound debris strengthens humoral defense mechanisms sufficiently to retard proliferation of local pathogens. Balsam Peru is an effective capillary bed stimulant used to increase circulation in the wound site area. Also, Balsam Peru has a mildly bactericidal action. Castor Oil improves epithelialization by reducing premature epithelial desiccation and cornification. Also, it can act as a protective covering and aids in the reduction of pain.

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  • INDICATIONS

    VASOLEX™ OINTMENT is used to promote wound healing and the treatment of decubitus ulcers, varicose ulcers and dehiscent wounds.

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  • USES

    VASOLEX™ 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. VASOLEX™ OINTMENT can relieve pain and promote healing.

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  • 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.

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  • USUAL DOSAGE

    Apply a thin film of VASOLEX™ 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.

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  • HOW SUPPLIED

    VASOLEX™ OINTMENT (Trypsin USP, Balsam Peru, Castor Oil USP) is supplied as follows:

             SIZE NDC NUMBER
    30 GRAM TUBE 58980-790-11
    60 GRAM TUBE 58980-790-21
    5 GRAM PACKETTE × 60 58980-790-50

    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. Protect from freezing.

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  • SPL UNCLASSIFIED SECTION

    Distributed by
    STRATUS
    PHARMACEUTICALS INC

    Manufactured by
    Sonar Products, Inc.
    Carlstadt, NJ 07072

    Exclusively for
    Stratus Pharmaceuticals Inc.
    12379 Southwest 130th Street
    Miami, Florida 33186

    Customer Service
    Telephone: 1-800-442-7882
    Fax: 305-254-6875

    ©2006 Stratus Pharmaceuticals Inc.

    Rev. JG-VOIN2012-102

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  • PRINCIPAL DISPLAY PANEL - 30 g Tube Box

    NDC 58980-790-11

    Net Wt. 30 grams

    VASOLEXOINTMENT

    STRATUS
    PHARMACEUTICALS INC

    (Trypsin USP, Balsam Peru, Castor Oil USP)

    Rx only

    Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

    PRINCIPAL DISPLAY PANEL -30 g Tube Box
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  • INGREDIENTS AND APPEARANCE
    VASOLEX 
    trypsin, castor oil, and balsam peru ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-790
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Trypsin (Trypsin) Trypsin 90 [USP'U]  in 1 g
    Castor Oil (Castor Oil) Castor Oil 788 mg  in 1 g
    Balsam Peru (Balsam Peru) Balsam Peru 87 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Glycine  
    Petrolatum  
    Proline  
    Taurine  
    Glyceryl Monostearate  
    Product Characteristics
    Color BROWN (yellow to brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-790-21 1 in 1 BOX
    1 60 g in 1 TUBE
    2 NDC:58980-790-50 60 in 1 BOX
    2 5 g in 1 PACKET
    3 NDC:58980-790-11 1 in 1 BOX
    3 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/07/2007
    Labeler - Stratus Pharmacuticals (789001641)
    Registrant - Sonar Products, Inc (104283945)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc 104283945 MANUFACTURE(58980-790), LABEL(58980-790)
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