{"active_ingredient":["Active ingredient Pramoxine HCL 1% w/w"],"do_not_use":["Do not exceed the recommended daily dosage unless directed by a Physician.","Do not put this product into rectum by using fingers or any applicator."],"dosage_and_administration":["Directions Shake well before using. When practical, cleansethe 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 this product. Adults and children 12 years of age and older: apply to affected area up to five times daily. Children under 12 years of age, consult a Physician."],"effective_time":"20251002","id":"a3ed95de-1df1-46d0-bc60-938274ffbc7d","inactive_ingredient":["Inactive ingredients Carbomer 940, Cetyl Alcohol, Di-isopropyl Adipate, Dimethicone, Glycerin 99.7%, Lanolin Anhydrous, Light Mineral Oil, PEG 40 Stearate, Potassium Sorbate, Purified Water, Sorbic Acid, Stearic Acid, Stearyl Alcohol, Trolamine, Ultimate White Petrolatum."],"indications_and_usage":["Use for the temporary relief of itching and discomfort in the perianal area."],"keep_out_of_reach_of_children":["Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away."],"openfda":{"application_number":["M015"],"brand_name":["Pramoxine Hydrochloride Anorectal"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Stratus Pharmaceuticals"],"package_ndc":["58980-522-40","58980-522-80"],"product_ndc":["58980-522"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1246075"],"spl_id":["a3ed95de-1df1-46d0-bc60-938274ffbc7d"],"spl_set_id":["39a16b66-b0e9-412f-8773-8dec0a1227e0"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 mL Bottle Box NDC 58980-522-40 ANORECTAL PRAMOXINE HYDROCHLORIDE 1% ANORECTAL FAST RELIEF FROM ITCH AND DISCOMFORT ANORECTAL (hemorrhoidal) LOTION Net 4 fl oz (118 mL) Principal Display Panel - 118 mL Bottle Box"],"purpose":["Purpose Local Anesthetic"],"questions":["Questions or comments? Call us at: 1-800-442-7882"],"set_id":"39a16b66-b0e9-412f-8773-8dec0a1227e0","spl_product_data_elements":["Pramoxine Hydrochloride Anorectal Pramoxine Hydrochloride Pramoxine Hydrochloride Pramoxine CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL PALMITATE Glycerin Light Mineral Oil WHITE PETROLATUM STEARIC ACID TROLAMINE PEG-40 MONOSTEARATE Stearyl Alcohol LANOLIN POTASSIUM SORBATE DIISOPROPYL ADIPATE Sorbic Acid Water"],"spl_unclassified_section":["Drug Facts","Distributed by: STRATUS PHARMACEUTICALS INC Miami, Florida 33186"],"stop_use":["Stop use and ask a Physician if Condition worsens Symptoms do not improve in 7 days Allergic reactions develop to ingredients in this product Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase"],"version":"1","warnings":["Warnings for external use only. Do not exceed the recommended daily dosage unless directed by a Physician. Do not put this product into rectum by using fingers or any applicator. Stop use and ask a Physician if Condition worsens Symptoms do not improve in 7 days Allergic reactions develop to ingredients in this product Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away."]}