{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Hemorrhoidal Pain Relief with Aloe and VitaminE Hemorrhoidal Pain Relief with Aloe and VitaminE PROPYLENE GLYCOL SODIUM CITRATE STEARIC ACID WATER MINERAL OIL CETYL PALMITATE LANOLIN METHYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CETOSTEARYL ALCOHOL PETROLATUM PETROLATUM PRAMOXINE HYDROCHLORIDE PRAMOXINE ISOPROPYL MYRISTATE GLYCERYL MONOSTEARATE PROPYLPARABEN GLYCERIN GLYCERIN ALOE POLYSORBATE 60 CETYL ESTERS WAX .ALPHA.-TOCOPHEROL ACETATE" ], "active_ingredient": [ "Drug Facts - Active Ingredients Glycerin 14.4% Phenylephrine Hydrochloride 0.25% Pramoxine Hydrochloride 1% White petrolatum 15%" ], "purpose": [ "Purpose Glycerin 14.4% ..................................................................... Protectant Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor Pramoxine Hydrochloride 1% ...................................... Local Anesthetic White petrolatum 15% .......................................................... Protectant" ], "intended_use_of_the_device": [ "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." ], "warnings": [ "Warnings: For external use only" ], "ask_doctor": [ "​Ask a doctor before use if you have 􀁑􀀃Heart disease 􀁑􀀃High blood pressure 􀁑􀀃Thyroid disease 􀁑􀀃Diabetes􀁑􀀃Difficulty in urination due to enlargement of 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." ], "when_using": [ "When using this product: 􀁑􀀃Do not exceed the recommended daily dosage unless directed by a doctor 􀁑􀀃Do not put in the rectum by using fingers or any mechanical device or applicator" ], "stop_use": [ "Stop use and ask doctor if: 􀁑􀀃Bleeding occurs 􀁑􀀃Condition worsens or does not improve within 7 days 􀁑􀀃An allergic reaction occurs 􀁑􀀃The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use." ], "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)." ], "dosage_and_administration": [ "Directions: 􀁑􀀃Adults: 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 to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. 􀁑􀀃For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing well, then gently insert dispensing cap partway into the anus. Thoroughly cleanse dispensing cap after each use and replace cover. 􀁑􀀃Children under 12 years of age: ask a doctor." ], "inactive_ingredient": [ "Inactive ingredients: aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate" ], "other_safety_information": [ "Questions? Questions? 1 (877) 477-8633" ], "user_safety_warnings": [ "TAMPER EVIDENT: TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING" ], "safe_handling_warning": [ "Important Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product." ], "indications_and_usage": [ "Use swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation" ], "package_label_principal_display_panel": [ "Package label _Outer carton Pain Relief Cream with Aloe" ], "set_id": "076b5021-8ba0-0204-e063-6294a90a3337", "id": "076b5021-8ba1-0204-e063-6294a90a3337", "effective_time": "20231011", "version": "1", "openfda": { "application_number": [ "M015" ], "brand_name": [ "Hemorrhoidal Pain Relief with Aloe and VitaminE" ], "generic_name": [ "HEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINE" ], "manufacturer_name": [ "NeilMed pharmaceuticals Inc." ], "product_ndc": [ "13709-324" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "RECTAL" ], "substance_name": [ "GLYCERIN", "PETROLATUM", "PHENYLEPHRINE HYDROCHLORIDE", "PRAMOXINE HYDROCHLORIDE" ], "spl_id": [ "076b5021-8ba1-0204-e063-6294a90a3337" ], "spl_set_id": [ "076b5021-8ba0-0204-e063-6294a90a3337" ], "package_ndc": [ "13709-324-01" ], "is_original_packager": [ true ], "upc": [ "0705928160033" ], "nui": [ "N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417" ], "pharm_class_epc": [ "Non-Standardized Chemical Allergen [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]" ], "pharm_class_cs": [ "Allergens [CS]", "Glycerol [CS]" ], "unii": [ "PDC6A3C0OX", "4T6H12BN9U", "04JA59TNSJ", "88AYB867L5" ] } } ] }