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Name:Vasolex
Manufacturer:Stratus Pharamceuticals, Inc
Category:Prescription Marketed Drugs


VASOLEX™ OINTMENT(Trypsin USP, Balsam Peru, Castor Oil USP)

VASOLEX - trypsin ointment 
Stratus Pharamceuticals, Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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VASOLEX™ OINTMENT
(Trypsin USP, Balsam Peru, Castor Oil USP)

Rx Only

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 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

Principal Display Panel - 30 gram Ointment Container

VASOLEX 
trypsin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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
Inactive Ingredients
Ingredient Name Strength
Castor Oil 788 mg  in 1 g
Balsam, Peru 87 mg  in 1 g
Product Characteristics
Color WHITE (off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58980-790-11 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 30 g in 1 TUBE This package is contained within the BOX (58980-790-11)

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

Revised: 07/2009 Stratus Pharamceuticals, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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