{"active_ingredient":["Active Ingredient Glycerol 14.4%","Active Ingredient Phenylephrine HCI 0.25%","Active Ingredient Lidocaine 5%","Active Ingredient White Petrolatum 15%"],"ask_doctor_or_pharmacist":["Ask a Doctor before use If you are presently taking a prescription drug for high blood pressure or depression."],"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. 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 Children under 12 years of age: ask a doctor"],"effective_time":"20260410","id":"4f1ef997-92ad-842f-e063-6294a90aab3f","inactive_ingredient":["Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Citric acid Monohydrate, Dexpanthenol, EDTA Disodium, Light mineral oil, Methylparaban, Mono and di glycerides, Octadecyl alcohol, polysorbate 80, Propyl 4-hydroxybenzoate,, propylene glycol, purified water, Vitamin E."],"indications_and_usage":["Uses For temporary relief of pain, soreness, and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue 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 with Lidocaine"],"generic_name":["GLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUM"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals Usa Llc"],"nui":["N0000175682","M0000897","N0000175426","N0000175976","N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["69396-181-01","69396-181-03"],"pharm_class_cs":["Amides [CS]","Allergens [CS]","Glycerol [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]","Non-Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]","Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"product_ndc":["69396-181"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2642220"],"spl_id":["4f1ef997-92ad-842f-e063-6294a90aab3f"],"spl_set_id":["4f1ef866-c4af-989b-e063-6294a90a148e"],"substance_name":["LIDOCAINE","WHITE PETROLATUM","GLYCERIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["98PI200987","B6E5W8RQJ4","PDC6A3C0OX","04JA59TNSJ"],"upc":["0850058161457","0850058161464"]},"package_label_principal_display_panel":["LABEL 4043-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 031826 CDER","LABEL 404303-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 3PK_BOX 022326 CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast Feeding Ask a health professional before use"],"purpose":["Purpose Protectant","Purpose Vasoconstrictor","Purpose Local Anesthetic","Purpose Protectant"],"questions":["Questions or Comments Call 1-888-296-9067"],"set_id":"4f1ef866-c4af-989b-e063-6294a90a148e","spl_product_data_elements":["Hemorrhoidal Cream with Lidocaine Glycerol, Phenylephine, Pramoxine, Petrolatum EDETATE DISODIUM PROPYLPARABEN SODIUM .ALPHA.-TOCOPHEROL STEARYL ALCOHOL CETYL ALCOHOL DEXPANTHENOL ALOE VERA LEAF LIGHT MINERAL OIL POLYSORBATE 80 PROPYLENE GLYCOL WATER METHYLPARABEN LIDOCAINE LIDOCAINE WHITE PETROLATUM PETROLATUM GLYCERIN GLYCERIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CITRIC ACID MONOHYDRATE GLYCERYL MONO- AND DICAPRYLATE"],"spl_unclassified_section":["Drug Facts","Other Information Store at room temperature 20º-25ºC (68º-77ºF) This product is not manufactured or distributed by Haleon US Holdings LLC, distributor of Preparation H® Rapid Relief Cream","Distributed By Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301, USA 1-888-296-9067 www.trifecta-pharma.com SKU: 4043-FBA"],"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":"1","warnings":["Warnings For External Use Only Ask doctor brfore use if you have Heart Disease High Blood pressure Thyroid Disease Diabetes Difficulty urinating due to an enlarged prostate gland"],"when_using":["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."]}