{"effective_time":"20120927","id":"229e6420-ed55-46c6-a696-471e008d4562","indications_and_usage":["INDICATIONS Varicose Ulcers Debride Eschar Dehiscent Wounds Decubital Ulcers Sunburn Wound Healing GRANULEX will relieve pain and promote healing; debrides eschar and necrotic tissue physiologically; stimulates vascular bed; improves epithelization by reducing premature epithelial desiccation and cornification; reduces odor from malodorous necrotic wounds."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 51079-621-8 1 GRANULEX Granulex 2 oz. Label"],"set_id":"06ec7e77-2fbf-4722-94d8-2c083a1759b3","spl_product_data_elements":["Granulex trypsin, balsam peru and castor oil CASTOR OIL CASTOR OIL BALSAM PERU BALSAM PERU TRYPSIN, UNSPECIFIED FORM TRYPSIN, UNSPECIFIED FORM WATER"],"spl_unclassified_section":["NDC 51079-621-81 GRANULEX SHAKE WELL BEFORE EACH USAGE Hold Upright to Spray The nozzle of the canister is designed for large volume delivery of medication, therefore, proper coverage of the wound site is achieved quickly. PHYSIOLOGICAL DEBRIDEMENT CAPILLARY BED STIMULANT PROMOTES GRANULATION Each gram contains: Trypsin, USP.........................0.12 mg Balsam Peru..........................87.0 mg Castor Oil, USP...................788.0 mg With an emulsifier and propellants (Water Dispersible) Rx only Mylan.com Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Net Wt. 2 oz. (56.7g)","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 apply a wet dressing. Apply twice daily or as often as necessary. To remove, wash gently with water. When applied to a sensitive area, a temporary stinging sensation may be noted."],"version":"3","warnings":["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. 301.3 Contents: Net weight 2 oz. (56.7g) Inert propellant 25% of total content."]}