VENELEX () [STRATUS PHARMACEUTICALS INC]

VENELEX () [STRATUS PHARMACEUTICALS INC]
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NDC 58980-780-11, 58980-780-21, 58980-780-50
Set ID 13291e03-6f75-403b-afc4-c44a10ca0083
Category MEDICAL DEVICE
Packager STRATUS PHARMACEUTICALS INC
Generic Name
Product Class
Product Number
Application Number NAD
  • SPL UNCLASSIFIED SECTION

    WOUND DRESSING

    Rx Only

  • DESCRIPTION

    VENELEX™ OINTMENT contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

  • ACTION

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

  • INDICATIONS

    VENELEX™ 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

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

  • USES

    VENELEX™ 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 VENELEX™ 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

    VENELEX™ OINTMENT is supplied as follows:

    SIZENDC NUMBER
    30 GRAM TUBE58980-780-11
    60 GRAM TUBE58980-780-21
    5 GRAM PACKETTE × 6058980-780-50

    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

    VENELEX™ OINTMENT

    WOUND DRESSING

    Rx only

    PRINCIPAL DISPLAY PANEL - 60 gram Tube Box
  • INGREDIENTS AND APPEARANCE
    VENELEX 
    dressing,wound,occlusive
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58980-780
    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:58980-780-111 in 1 BOX
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NHRIC:58980-780-211 in 1 BOX
    260 g in 1 TUBE; Type 0: Not a Combination Product
    3NHRIC:58980-780-5060 in 1 BOX, UNIT-DOSE
    35 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Exempt deviceNAD09/15/2017
    Labeler - STRATUS PHARMACEUTICALS INC (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE, LABEL, PACK