{"active_ingredient":["Active Ingredient Glycerol 14.4%","Active Ingredient Phenylephrine HCI 0.25%","Active Ingredient Pramoxine HCI 1%","Active Ingredient Petrolatum 15%"],"dosage_and_administration":["Directions Adults: When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening tube, puncture foil seal with top end of cap Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement"],"effective_time":"20251118","id":"43e0c50f-9d84-3f1c-e063-6394a90a9a23","inactive_ingredient":["Inactive Ingredients Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum"],"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 Cream"],"generic_name":["GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals Usa Llc"],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["69396-033-18","69396-033-33","69396-033-22"],"pharm_class_cs":["Allergens [CS]","Glycerol [CS]"],"pharm_class_epc":["Non-Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["69396-033"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1293649"],"spl_id":["43e0c50f-9d84-3f1c-e063-6394a90a9a23"],"spl_set_id":["804d7b1f-1be8-50c9-e053-2a91aa0a35d0"],"substance_name":["PRAMOXINE HYDROCHLORIDE","PETROLATUM","GLYCERIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["88AYB867L5","4T6H12BN9U","PDC6A3C0OX","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging Hemorrhoidal Cream","Label 403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 031925 CDER","LABEL 430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW"],"pregnancy_or_breast_feeding":["If Pregnant or Breast Feeding Ask doctor before use"],"purpose":["Purpose Protectant","Purpose Vasoconstrictor","Purpose Local Anesthetic","Purpose Protectant"],"questions":["Questions or Comments Call 1-888-296-9067"],"set_id":"804d7b1f-1be8-50c9-e053-2a91aa0a35d0","spl_product_data_elements":["Hemorrhoidal Cream Glycerol, Phenylephine, Pramoxine, Petrolatum PRAMOXINE HYDROCHLORIDE PRAMOXINE PETROLATUM PETROLATUM ALOE VERA LEAF GLYCERIN GLYCERIN GLYCERYL MONOSTEARATE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) CETYL ALCOHOL PROPYLPARABEN MINERAL OIL POLYSORBATE 80 PROPYLENE GLYCOL WATER STEARIC ACID XANTHAN GUM METHYLPARABEN"],"spl_unclassified_section":["Drug Facts","Other Information Store at room temperature 20º-25ºC (68º-77ºF) Do not use if tube seal is broken or missing This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®","Distributed By Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301, USA 1-888-296-9067 Product of PRC www.trifecta-pharma.com"],"stop_use":["Stop use and ask a doctor Bleeding occurs Condition worsens or does not improve within 7 days An allergic reaction develops The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase"],"version":"6","warnings":["Warnings For External Use Only Ask doctor brfore use if you have Heart Disease Thyroid Disease Diabetes Trouble urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription for high blood pressure or depression When using this product Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator"]}