{"active_ingredient":["Active ingredient Mineral Oil 14% Petrolatum 74.9% Phenylephrine HCI 0.25%"],"ask_doctor":["Ask a doctor before use if you have ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression."],"dosage_and_administration":["Directions ■ Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment. ■ Apply to affected areas up to 4 times daily. ■ EXTERNAL USE: Apply to affected area ■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover ■ Children under 12 years of age: consult a doctor"],"effective_time":"20250331","id":"1790da99-2a23-e2a2-e063-6394a90ac36f","inactive_ingredient":["Inactive ingredients benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax"],"indications_and_usage":["Uses ■ Helps relieve the local itching and discomfort associated with hemorrhoids ■ Temporarily shrinks hemorrhoidal tissue and relieves burning ■ Temporarily provides a coating for relief of anorectal discomforts ■ Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful"],"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":["M015"],"brand_name":["hemorrhoidal"],"generic_name":["MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Bionpharma Inc."],"package_ndc":["69452-448-38"],"product_ndc":["69452-448"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1372298"],"spl_id":["1790da99-2a23-e2a2-e063-6394a90ac36f"],"spl_set_id":["1790da99-2a22-e2a2-e063-6394a90ac36f"],"substance_name":["PETROLATUM","PHENYLEPHRINE HYDROCHLORIDE","MINERAL OIL"],"unii":["4T6H12BN9U","04JA59TNSJ","T5L8T28FGP"]},"package_label_principal_display_panel":["tube carton *compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment NDC 69452-448-38 a+ health TM hemorrhoidal ointment • reduces irritation • with applicator dye-free • phthalate-free • fragrance-free • relieves both internal and external hemorrhoid symptoms • temporarily shrinks swollen hemorrhoidal tissue • prompt, soothing relief from painful burning, itching and discomfort net wt. 2 oz image001"],"pregnancy_or_breast_feeding":["If pregnant or breast- feeding, ask a health professional before use."],"purpose":["Purpose Protectant Protectant Vasoconstrictor"],"set_id":"1790da99-2a22-e2a2-e063-6394a90ac36f","spl_product_data_elements":["hemorrhoidal mineral oil, petrolatum, phenylephrine hcl .ALPHA.-TOCOPHEROL ACETATE WHITE WAX PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID BUTYLATED HYDROXYANISOLE CORN OIL LANOLIN GLYCERIN LANOLIN ALCOHOLS METHYLPARABEN MINERAL OIL MINERAL OIL WATER PARAFFIN PROPYLPARABEN THYME OIL"],"spl_unclassified_section":["READ AND KEEP CARTON FOR COMPLETE INFORMATION *This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment. Manufactured for: Bionpharma Inc., Princeton, NJ 08540 GUJ/DRUGS/G/25/2134 MADE IN INDIA L0000812 R0424 LOT & EXP."],"stop_use":["Stop use and ask a doctor if ■ condition worsens or does not improve within 7 days ■ bleeding occurs ■ introduction of applicator into the rectum causes additional pain"],"storage_and_handling":["Other information ■ Store at 15°C – 30°C (59°F – 86°F) ■ Lot No. & Expiry Date: See box or crimp of tube"],"version":"1","warnings":["Warnings For external and/or intrarectal use only"],"when_using":["When using this product do not exceed the recommended daily dosage unless directed by a doctor."]}