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Venelex Ointment

Generic Name: castor oil and balsam peru
Dosage Form: ointment

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.

VENELEX™ OINTMENT
(Balsam Peru and Castor Oil USP)

Rx Only

Venelex Ointment Description

Each gram of VENELEX™ OINTMENT contains: ACTIVES: Balsam Peru 87.0mg and Castor Oil USP 788.0mg in an ointment base of: INACTIVES: Glyceryl Monostearate and White Petrolatum.

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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

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

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. VENELEX™ 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 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 is Venelex Ointment Supplied

VENELEX™ OINTMENT (Balsam Peru and Castor Oil USP) is supplied as follows:

SIZE NDC NUMBER
60 GRAM TUBE 58980-780-21

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. PG-VEOIN2009-10

PRINCIPAL DISPLAY PANEL - 60 gram Carton

NDC 58980-780-21
Net Wt. 60 grams

VENELEX™ OINTMENT
(Balsam Peru and Castor Oil USP)

STRATUS
PHARMACEUTICALS INC

Rx only

Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186

VENELEX 
castor oil and balsam, peru ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-780
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Castor Oil (Castor Oil) Castor Oil 788 mg  in 1 g
Balsam, Peru (Balsam, Peru) 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
1 NDC:58980-780-21 1 TUBE (TUBE) in 1 BOX
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/29/2009
Labeler - Stratus Pharamceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 10/2009
 
Stratus Pharamceuticals, Inc



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