{"active_ingredient":["Active ingredients Phenylephrine HCl 0.25% Pramoxine HCl 1% Purpose Vasoconstrictor Local anesthetic"],"ask_doctor":["Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression."],"do_not_use":["Do not use this product if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor."],"dosage_and_administration":["Directions • : when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. • when first opening the 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 Children under 12 years of age: ask a doctor. Adults"],"effective_time":"20231106","id":"0976dfc5-c33b-11fe-e063-6294a90aa2bb","inactive_ingredient":["Inactive ingredients Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol."],"indications_and_usage":["Uses • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid 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":["SIMPLE PROMISE Simple H Hemorrhoid Relief Cream"],"generic_name":["PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["SIMPLE PROMISE PTE LTD"],"package_ndc":["83311-335-00"],"product_ndc":["83311-335"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1293856"],"spl_id":["0976dfc5-c33b-11fe-e063-6294a90aa2bb"],"spl_set_id":["f6622caa-3b31-9b07-e053-2a95a90a8a51"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","PRAMOXINE HYDROCHLORIDE"],"unii":["04JA59TNSJ","88AYB867L5"]},"package_label_principal_display_panel":["Package Labeling: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, 2oz/56.7g Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Vasoconstrictor Local anesthetic"],"set_id":"f6622caa-3b31-9b07-e053-2a95a90a8a51","spl_product_data_elements":["SIMPLE PROMISE Simple H Hemorrhoid Relief Cream PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE WATER ALOE VERA LEAF BEHENTRIMONIUM METHOSULFATE SHEA BUTTER CALENDULA OFFICINALIS FLOWER CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETOSTEARYL ALCOHOL CETYL ALCOHOL CUCUMBER DECYL GLUCOSIDE DIMETHICONE GLYCERIN GLYCERYL LAURATE GLYCERYL MONOSTEARATE GLYCYRRHIZA GLABRA HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK ISOPROPYL MYRISTATE PEG-100 STEARATE PETROLATUM POLYSORBATE 20 SODIUM HYDROXIDE STEARIC ACID STEARYL ALCOHOL EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM CORN PROPANEDIOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE"],"spl_unclassified_section":["Drug Facts","Other information • store at 20-25°C (68-77°F) • do not use if printed safety seal on cap is broken or missing"],"stop_use":["Stop use and ask a doctor if • condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase."],"version":"2","warnings":["Warnings For external use only Do not use this product if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor. 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 exceed the recommended daily dosage unless directed by a doctor. • attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: In case of bleeding, consult a doctor promptly. Stop use and ask a doctor if • condition worsens or does not improve within 7 days • an allergic reaction develops • the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. 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."],"when_using":["When using this product • do not exceed the recommended daily dosage unless directed by a doctor. • attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE: In case of bleeding, consult a doctor promptly."]}