Home > Drugs A-Z > Venelex

Venelex (Stratus Pharamceuticals, Inc)

Available Formats

Dosage Form Package Information Links
OINTMENT 1 TUBE in 1 BOX (58980-780-21) > 60 g in 1 TUBE Label Information

Complete Venelex Information

  • SPL UNCLASSIFIED SECTION

    WOUND DRESSING

    Rx Only


  • DESCRIPTION

    VENELEXâ„¢ OINTMENT contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.


  • ACTION

    VENELEXâ„¢ OINTMENT helps to deodorize and protectively cover pressure wounds (ulcers). VENELEXâ„¢ OINTMENT provides a moist wound environment. The moisturizing properties of VENELEXâ„¢ OINTMENT may also help in the prevention of cracking around the edges of sores.


  • INDICATIONS

    VENELEXâ„¢ 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

    VENELEXâ„¢ OINTMENT is contraindicated in persons who have shown hypersensitivity to Balsam Peru, Petrolatum or any of the other ingredients used in this ointment.


  • USES

    VENELEXâ„¢ 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 VENELEXâ„¢ 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

    VENELEXâ„¢ OINTMENT is supplied as follows:

    SIZE NDC NUMBER
    30 GRAM TUBE 58980-780-11
    60 GRAM TUBE 58980-780-21
    5 GRAM PACKETTE × 60 58980-780-50

    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. [See USP Controlled Room Temperature]. Protect from freezing. See crimp for lot number and expiration date.


  • SPL UNCLASSIFIED SECTION

    Distributed:
    Stratus Pharmaceuticals Inc.
    Miami, Florida 33186

    ©2006 Stratus Pharmaceuticals Inc.
    Rev. VEOIN2017-0701


  • PRINCIPAL DISPLAY PANEL - 60 gram Tube Box

    STRATUS
    PHARMACEUTICALS INC

    NDC 58980-780-21
    Net Wt. 60 grams

    VENELEXâ„¢ OINTMENT

    WOUND DRESSING

    Rx only

    PRINCIPAL DISPLAY PANEL - 60 gram Tube Box

  • INGREDIENTS AND APPEARANCE
    VENELEX 
    dressing,wound,occlusive
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58980-780
    Route of Administration TOPICAL
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:58980-780-11 1 in 1 BOX
    1 30 g in 1 TUBE; Type 0: Not a Combination Product
    2 NHRIC:58980-780-21 1 in 1 BOX
    2 60 g in 1 TUBE; Type 0: Not a Combination Product
    3 NHRIC:58980-780-50 60 in 1 BOX, UNIT-DOSE
    3 5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Exempt device NAD 09/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    TARMAC PRODUCTS INC 059890491 MANUFACTURE, LABEL, PACK