{"active_ingredient":["Active ingredient Pramoxine hydrochloride 1%"],"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 • dispense 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":"20250815","id":"146e02e7-5477-4730-bdb1-be005dc57c4f","inactive_ingredient":["Inactive ingredients cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine"],"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":{"application_number":["M346"],"brand_name":["PROCTOFOAM NS"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Viatris Specialty LLC"],"package_ndc":["0037-6823-15"],"product_ndc":["0037-6823"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["828365","828367"],"spl_id":["146e02e7-5477-4730-bdb1-be005dc57c4f"],"spl_set_id":["cddc8d81-21b8-11e4-8c21-0800200c9a66"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"other_safety_information":["Other information • store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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 49°C (120°F)"],"package_label_principal_display_panel":["Principal Display Panel – 1% NDC 0037-6823-15 TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals ® seal on ends of carton are broken or missing. proctofoam ® non-steroid pramoxine hydrochloride 1% hemorrhoidal foam For temporary relief of hemorrhoidal pain and itching STORE UPRIGHT NET WT. 0.53 OZ (15 g) Drug Facts Active ingredient Purpose Pramoxine hydrochloride 1%. . . . . . . . Local anesthetic Use for the temporary relief of pain and itching associated with hemorrhoids Warnings For external use only When using this product • do not exceed the recommended daily dosage unless directed by a doctor • 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 Stop use and ask a doctor if • rectal bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction occurs to the ingredients in this product • symptom being treated does not subside • redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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 • dispense 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 Drug Facts (continued) Other information • store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 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 49°C (120°F) Drug Facts (continued) Inactive ingredients cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine Questions? 1-888-350-1908 Distributed by: MEDA PHARMACEUTICALS ® Canonsburg, PA 15317 U.S.A. ©2025 Viatris Inc. PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company. 117789 UC-82315-15-05 Proctofoam Hydrochloride Foam Carton Label"],"purpose":["Purpose Local anesthetic"],"questions":["Questions? 1-888-350-1908 Distributed by: Meda Pharmaceuticals Inc. Canonsburg, PA 15317 U.S.A. © 2025 Viatris Inc. PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company.."],"set_id":"cddc8d81-21b8-11e4-8c21-0800200c9a66","spl_product_data_elements":["PROCTOFOAM NS pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE CETYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE METHYLPARABEN LAURETH-23 POLYOXYL 40 STEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER TROLAMINE ISOBUTANE PROPANE"],"version":"6","warnings":["Warnings For external use only When using this product • do not exceed the recommended daily dosage unless directed by a doctor • 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 Stop use and ask a doctor if • rectal bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction occurs to the ingredients in this product • symptom being treated does not subside • redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}