VENELEX by STRATUS PHARMACEUTICALS INC / TARMAC PRODUCTS INC VENELEX-

VENELEX by

Drug Labeling and Warnings

VENELEX by is a Other medication manufactured, distributed, or labeled by STRATUS PHARMACEUTICALS INC, TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

SIZE	NDC NUMBER
30 GRAM TUBE	58980-780-11
60 GRAM TUBE	58980-780-21
5 GRAM PACKETTE × 60	58980-780-50

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.

SPL UNCLASSIFIED SECTION

Distributed:
Stratus Pharmaceuticals Inc.
Miami, Florida 33186

©2006 Stratus Pharmaceuticals Inc.
Rev. VEOIN2017-0701

PRINCIPAL DISPLAY PANEL - 60 gram Tube Box

STRATUS
PHARMACEUTICALS INC

NDC: 58980-780-21
Net Wt. 60 grams

VENELEX™ OINTMENT

WOUND DRESSING

Rx only

INGREDIENTS AND APPEARANCE

VENELEX 
dressing,wound,occlusive

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:58980-780
Route of Administration	TOPICAL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
BALSAM PERU (UNII: 8P5F881OCY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:58980-780-11	1 in 1 BOX
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NHRIC:58980-780-21	1 in 1 BOX
2		60 g in 1 TUBE; Type 0: Not a Combination Product
3	NHRIC:58980-780-50	60 in 1 BOX, UNIT-DOSE
3		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Exempt device	NAD	09/15/2017

Labeler - STRATUS PHARMACEUTICALS INC (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE, LABEL, PACK