Trypsin

Description

GRANULEX is an aerosol spray. Each gram of GRANULEX contains: 0.12 mg trypsin USP, 87.0 mg balsam peru, 788.0 mg castor oil USP, an emulsifier and propellants (water dispersible).

Indications and Usage

GRANULEX is indicated for the treatment of varicose ulcers, dehiscent wounds, decubital ulcers, sunburn and debridement of eschar. It is also used for wound healing.

GRANULEX will relieve pain and promote healing; debrides eschar and necrotic tissue physiologically; stimulates vascular bed; improves epithelization by reducing premature epithelial dessication and cornification; reduces odor from malodorous necrotic wounds.

DIRECTIONS

Shake well before spraying. Hold upright and approximately 12 inches from the area to be treated. Press valve and coat wound rapidly. Wound may be left unbandaged or a wet dressing may be applied. Apply twice daily or as often as necessary. To remove, wash gently with water. When applied to sensitive area, a temporary stinging sensation may be noted.

WARNING

Do not use on fresh arterial clots. Avoid spraying in eyes. Flammable, do not expose to fire or open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

NDC Code            Net Weight

62794-002-50       2 oz. (56.7g)

62794-002-51       4 oz. (113.4g)

Inert propellant      25% of total content.

BERTEK PHARMACEUTICALS INC.

Morgantown, WV 26505

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