Label: VASOLEX- trypsin, castor oil and balsam peru ointment
- NDC Code(s): 58980-790-11, 58980-790-21, 58980-790-50
- Packager: Stratus Pharmacuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
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.Close
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.Close
VASOLEX™ OINTMENT is used to promote wound healing and the treatment of decubitus ulcers, varicose ulcers and dehiscent wounds.Close
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.Close
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.Close
- 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.Close
- HOW SUPPLIED
VASOLEX™ OINTMENT (Trypsin USP, Balsam Peru, Castor Oil USP) is supplied as follows:
SIZE NDC NUMBER 30 GRAM TUBE 58980-790-11 60 GRAM TUBE 58980-790-21 5 GRAM PACKETTE × 60 58980-790-50
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.
- SPL UNCLASSIFIED SECTION
Sonar Products, Inc.
Carlstadt, NJ 07072
Stratus Pharmaceuticals Inc.
12379 Southwest 130th Street
Miami, Florida 33186
©2006 Stratus Pharmaceuticals Inc.
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box
Net Wt. 30 grams
(Trypsin USP, Balsam Peru, Castor Oil USP)
Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186
- INGREDIENTS AND APPEARANCE
trypsin, castor oil, and balsam peru ointment
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58980-790 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trypsin (UNII: GV54A213NN) (Trypsin - UNII:GV54A213NN) Trypsin 90 [USP'U] in 1 g Castor Oil (UNII: D5340Y2I9G) (Castor Oil - UNII:D5340Y2I9G) Castor Oil 788 mg in 1 g Balsam Peru (UNII: 8P5F881OCY) (Balsam Peru - UNII:8P5F881OCY) Balsam Peru 87 mg in 1 g Inactive Ingredients Ingredient Name Strength Glycine (UNII: TE7660XO1C) Petrolatum (UNII: 4T6H12BN9U) Proline (UNII: 9DLQ4CIU6V) Taurine (UNII: 1EQV5MLY3D) Glyceryl Monostearate (UNII: 230OU9XXE4) Product Characteristics Color BROWN (yellow to brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-790-21 1 in 1 BOX 1 60 g in 1 TUBE 2 NDC:58980-790-50 60 in 1 BOX 2 5 g in 1 PACKET 3 NDC:58980-790-11 1 in 1 BOX 3 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/07/2007 Labeler - Stratus Pharmacuticals (789001641) Registrant - Sonar Products, Inc (104283945) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE(58980-790) , LABEL(58980-790)