Dosage Form: ointment
VASOLEX™ OINTMENT
(Trypsin USP, Balsam Peru, Castor Oil USP)
Rx Only
Vasolex Ointment 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.
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 a 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.
INDICATIONS
VASOLEX™ OINTMENT is used to promote wound healing and the treatment of decubitus ulcers, varicose ulcers and dehiscent wounds.
USES
VASOLEX™ 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™ can relieve pain and promote healing.
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 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.
How is Vasolex Ointment 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 25°C (77°F); excursions permitted to 15°-30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. See crimp for lot number and expiration date.
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-VOIN2009-06
PRINCIPAL DISPLAY PANEL - 30 gram Ointment Container
NDC 58980-790-11
Net Wt. 30 grams
VASOLEX™ OINTMENT
STRATUS
PHARMACEUTICALS INC
(Trypsin USP, Balsam Peru, Castor Oil USP)
Rx only
Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved other | 07/15/2009 | ||
| Labeler - Stratus Pharamceuticals, Inc (789001641) |
| Registrant - Sonar Products, Inc (104283945) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sonar Products, Inc | 104283945 | MANUFACTURE | |
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