{"active_ingredient":["Active ingredients Glycerin 14.4%, Phenylephrine HCl 0.25% Pramoxine HCl 1% White petrolatum 15% Purpose Protectant Vasoconstrictor Local anesthetic Protectant"],"ask_doctor":["Ask a doctor or pharmacist before use if you are • 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 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. apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement. apply externally or in the lower portion of the anal canal only. for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus. Children under 12 years of age: consult a doctor."],"effective_time":"20260407","id":"4ee1f506-399b-78b9-e063-6394a90ad640","inactive_ingredient":["Inactive ingredients aloe barbadensis leaf juice, carboxymethycellulose sodium, cetyl alcohol, methylparaben, mineral oil, mono-and di-glycerides, propylene glycol, propylparaben, purified water, stearic acid, tween 80, xanthan gum"],"indications_and_usage":["Uses • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful • temporarily shrinks hemorrhoidal tissue"],"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 (1-800-222-1222)."],"openfda":{"application_number":["M015"],"brand_name":["Thera Plus Hemorrhoidal"],"generic_name":["GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM"],"is_original_packager":[true],"manufacturer_name":["Fourstar Group USA, Inc."],"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"package_ndc":["80684-210-01"],"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":["80684-210"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1293649"],"spl_id":["4ee1f506-399b-78b9-e063-6394a90ad640"],"spl_set_id":["5d63bf97-29d2-4c71-97c3-85f425e86207"],"substance_name":["GLYCERIN","PHENYLEPHRINE HYDROCHLORIDE","PRAMOXINE HYDROCHLORIDE","WHITE PETROLATUM"],"unii":["PDC6A3C0OX","04JA59TNSJ","88AYB867L5","B6E5W8RQJ4"],"upc":["0049696700429"]},"package_label_principal_display_panel":["Package Labeling: Label3"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Protectant Vasoconstrictor Local anesthetic Protectant"],"questions":["Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST"],"set_id":"5d63bf97-29d2-4c71-97c3-85f425e86207","spl_product_data_elements":["Thera Plus Hemorrhoidal GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM ALOE VERA LEAF JUICE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CETYL ALCOHOL METHYLPARABEN MINERAL OIL PROPYLENE GLYCOL PROPYLPARABEN WATER STEARIC ACID POLYSORBATE 80 XANTHAN GUM GLYCERIN GLYCERIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE WHITE PETROLATUM GLYCERIN"],"spl_unclassified_section":["Drug Facts","Other information store at room temperature 68 °- 77° F (20° - 25° C)."],"stop_use":["Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. some people can develop allergic reactions to ingredients in this product."],"version":"1","warnings":["Warnings For external use only. Ask a doctor or pharmacist before use if you are • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are • presently taking a prescription drug for high blood pressure or depression. When using this product • do not put this product into the rectum by using fingers or any mechanical device or applicator • do not exceed recommended daily dosage unless directed by a doctor Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days the symptoms being treated do not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. some people can develop allergic reactions to ingredients in this product. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["When using this product • do not put this product into the rectum by using fingers or any mechanical device or applicator • do not exceed recommended daily dosage unless directed by a doctor"]}