VENELEX- dressing, wound, occlusive    
STRATUS PHARMACEUTICALS INC

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VENELEX™ OINTMENT

WOUND DRESSING

Rx Only

DESCRIPTION

VENELEX™ OINTMENT contains Balsam Peru, Castor Oil USP, Glyceryl Monostearate and White Petrolatum.

ACTION

VENELEX™ OINTMENT helps to deodorize and protectively cover pressure wounds (ulcers). VENELEX™ OINTMENT provides a moist wound environment. The moisturizing properties of VENELEX™ OINTMENT may also help in the prevention of cracking around the edges of sores.

INDICATIONS

VENELEX™ OINTMENT is a wound dressing for topical use in the management of chronic and acute wounds, and dermal ulcers including: pressure ulcers (Stage I-IV), venous stasis ulcers, diabetic ulcers, first and second degree burns, surgical wounds, traumatic wounds, superficial wounds, ulcers resulting from arterial insufficiency and grafted wound/donor sites.

CONTRAINDICATIONS

VENELEX™ OINTMENT is contraindicated in persons who have shown hypersensitivity to Balsam Peru, Petrolatum or any of the other ingredients used in this ointment.

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.

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 SUPPLIED

VENELEX™ OINTMENT is supplied as follows:

SIZENDC NUMBER
30 GRAM TUBE58980-780-11
60 GRAM TUBE58980-780-21
5 GRAM PACKETTE × 6058980-780-50

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. [See USP Controlled Room Temperature]. Protect from freezing. See crimp for lot number and expiration date.

Distributed:
Stratus Pharmaceuticals Inc.
Miami, Florida 33186

©2006 Stratus Pharmaceuticals Inc.
Rev. VEOIN2017-0701

PRINCIPAL DISPLAY PANEL - 56.70 g Tube Box

STRATUS
PHARMACEUTICALS INC

Reorder # 5898078021

Net Wt. 2 oz / 56.70 g

VENELEX™ WOUND DRESSING

OINTMENT

Rx only

PRINCIPAL DISPLAY PANEL - 56.70 g Tube Box
VENELEX 
dressing, wound, occlusive
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58980-780
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
BALSAM PERU (UNII: 8P5F881OCY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58980-780-111 in 1 BOX
130 g in 1 TUBE; Type 0: Not a Combination Product
2NHRIC:58980-780-211 in 1 BOX
260 g in 1 TUBE; Type 0: Not a Combination Product
3NHRIC:58980-780-501 in 1 BOX, UNIT-DOSE
35 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceNAD09/15/2017
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
TARMAC PRODUCTS INC059890491MANUFACTURE, LABEL, PACK

Revised: 4/2021
Document Id: b5fb248a-8f8e-481e-acc2-cd277110d562
Set id: 13291e03-6f75-403b-afc4-c44a10ca0083
Version: 6
Effective Time: 20210401
 
STRATUS PHARMACEUTICALS INC