Your browser does not support JavaScript! VASOLEX (TRYPSIN, CASTOR OIL, AND BALSAM PERU) OINTMENT [STRATUS PHARMACUTICALS]
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VASOLEX (trypsin, castor oil, and balsam peru) ointment
[Stratus Pharmacuticals]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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 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.

INDICATIONS

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

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.

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:

         SIZENDC NUMBER
30 GRAM TUBE58980-790-11
60 GRAM TUBE58980-790-21
5 GRAM PACKETTE × 6058980-790-50

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.

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

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
VASOLEX 
trypsin, castor oil, and balsam peru ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:58980-790
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Trypsin (Trypsin) Trypsin90 [USP'U]  in 1 g
Castor Oil (Castor Oil) Castor Oil788 mg  in 1 g
Balsam Peru (Balsam Peru) Balsam Peru87 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycine 
Petrolatum 
Proline 
Taurine 
Glyceryl Monostearate 
Product Characteristics
ColorBROWN (yellow to brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-790-211 in 1 BOX
160 g in 1 TUBE
2NDC:58980-790-5060 in 1 BOX
25 g in 1 PACKET
3NDC:58980-790-111 in 1 BOX
330 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/07/2007
Labeler - Stratus Pharmacuticals (789001641)
Registrant - Sonar Products, Inc (104283945)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products, Inc104283945MANUFACTURE(58980-790), LABEL(58980-790)

Revised: 7/2012
 
Stratus Pharmacuticals

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