Saturday, 30 June 2012

Venelex Ointment





Dosage Form: ointment
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.



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:






SIZENDC NUMBER
60 GRAM TUBE58980-780-21

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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)58980-780
Route of AdministrationTOPICALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Castor Oil (Castor Oil)Castor Oil788 mg  in 1 g
Balsam, Peru (Balsam, Peru)Balsam, Peru87 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (Off white)Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
158980-780-211 TUBE In 1 BOXcontains a TUBE
160 g In 1 TUBEThis package is contained within the BOX (58980-780-21)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/29/2009


Labeler - Stratus Pharamceuticals, Inc (789001641)









Establishment
NameAddressID/FEIOperations
Sonar Products, Inc104283945MANUFACTURE
Revised: 10/2009Stratus Pharamceuticals, Inc




More Venelex Ointment resources


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