{"active_ingredient":["Active Ingredient Phenylephrine HCI 0.25%","Active Ingredient Mineral Oil 14%","Active Ingredient Petrolatum 74.9%"],"dosage_and_administration":["Directions Adults and children 12 years of age and older for topical use: Clean the affected area and pat or dab dry before applying ointment Apply to the affected area up to 4 times daily, especially after bowel movement Attach included applicator to tube Lubricate applicator tip and gently insert into rectum Thoroughly clean applicator after each use and replace cover Children under 12 years of age: ask a doctor before use"],"effective_time":"20250609","id":"37247f04-c552-7e53-e063-6394a90a162e","inactive_ingredient":["Inactive Ingredients Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol"],"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 profects 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":["HemorrhoidalOintment"],"generic_name":["MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA LLC"],"package_ndc":["69396-020-02","69396-020-01","69396-020-33","69396-020-44"],"product_ndc":["69396-020"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1372298"],"spl_id":["37247f04-c552-7e53-e063-6394a90a162e"],"spl_set_id":["4eb3c9ac-268a-5246-e054-00144ff88e88"],"substance_name":["MINERAL OIL","PETROLATUM","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["T5L8T28FGP","4T6H12BN9U","04JA59TNSJ"],"upc":["0040232454875"]},"package_label_principal_display_panel":["4042 HEMORRHOIDAL OINTMENT 2OZ UPC 053025 CDER","PACKAGE LABEL 404203-FBA GLOBE HEMORRHOIDAL OINTENT 2OZ 3PK_BOX 060525 CDER","404204-FBA GLOBE HEMORRHOIDAL OINTMENT 2OZ 4PK_BOX 060525 CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast-Feeding Ask a doctor before use"],"purpose":["Purpose Vasoconstrictor","Purpose Protectant","Purpose Protectant"],"set_id":"4eb3c9ac-268a-5246-e054-00144ff88e88","spl_product_data_elements":["HemorrhoidalOintment Mineral Oil, Petrolatum, Phenylephrine HCI CETYL ALCOHOL BEESWAX MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PROPYLPARABEN METHYLPARABEN GLYCERIN BENZOIC ACID LAURETH-23 STEARYL ALCOHOL"],"spl_unclassified_section":["Drug Facts","Distributed By: Trifecta Pharamceuticals USA, LLC.® 101 NE Third Ave. Suite 1500 Ft. Lauderdale, FL. 33301 USA www.trifecta-pharma.com"],"stop_use":["Stop Use and Ask Doctor if Bleeding occurs Condition worsens or does not improve within 7 days Introduction of applicator into the rectum causes additional pain"],"storage_and_handling":["Other Information Store at room temperature 20°-25°C (68°-77°F) Close cap tightly after use Questions? Call 1-888-296-9067"],"version":"10","warnings":["Warnings For external and/or anorectal use only Ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription drug for high blood pressure"]}