{"active_ingredient":["Active ingredient Pramoxine hydrochloride 1%"],"ask_doctor":["Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly."],"dosage_and_administration":["Directions • Place cap on container. Shake well before use. • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam ® . • Dispense proctofoam ® onto a clean tissue and apply externally to the affected area up to 5 times daily. • Children under 12 years of age: consult a physician."],"effective_time":"20100114","id":"26360995-0e1e-4721-b5f3-72e9e333af18","inactive_ingredient":["Inactive ingredients cetyl alcohol, glyceryl monostearate and PEG-100 stearate blend, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane."],"indications_and_usage":["Use for the temporary relief of pain and itching associated with hemorrhoids"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 g Carton NDC 68220-143-15 STORE UPRIGHT proctofoam ® non- steroid (pramoxine hydrochloride 1%) hemorrhoidal foam For temporary relief of hemorrhoidal pain and itching For External Use Only ALAVEN ® PHARMACEUTICAL LLC 15 g net wt (0.53 oz) Principal Display Panel - 15 g Carton","PRINCIPAL DISPLAY PANEL - 15 g Label NDC 68220-143-15 For External Use Only proctofoam ® non-steroid (pramoxine hydrochloride 1%) hemorrhoidal foam DIRECTIONS: Place cap on container. Shake well before use. Apply externally to affected area up to 5 times daily. See carton for additional directions for use. WARNINGS: Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body. CAUTION: Do not insert any part of the aerosol container into the rectum. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). STORE UPRIGHT AT CONTROLLED ROOM TEMPERATURE 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). DO NOT REFRIGERATE. Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30067, USA For medical inquiries, call 1-888-317-0001 15 g net weight (0.53 oz) Rev. 05/08 Principal Display Panel - 15 g Label"],"purpose":["Purpose Local Anesthetic"],"questions":["Questions? 1-888-317-0001"],"set_id":"beae280c-e321-46ea-ac1f-b7dfdf867374","spl_product_data_elements":["Proctofoam pramoxine hydrochloride pramoxine hydrochloride pramoxine cetyl alcohol glyceryl monostearate methylparaben polyoxyl 40 stearate propylene glycol propylparaben water trolamine isobutane propane"],"spl_unclassified_section":["Drug Facts","ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30067, USA Rev. 08/08"],"stop_use":["Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician."],"storage_and_handling":["Other information • Store upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). • Do not refrigerate. • Contents of the container are under pressure. Do not burn or puncture the aerosol container. • Do not store at temperatures above 120°F (49°C)."],"version":"2","warnings":["Warnings Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum. Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum."]}