{"active_ingredient":["Active ingredients Glycerin 14.4% Petrolatum 15% Phenylephrine HCl 0.25% Pramoxine HCl 1%"],"ask_doctor":["Ask a doctor before use if you have ▪ heart disease ▪ high blood pressure ▪ diabetes ▪ thyroid disease ▪ trouble urinating due to an enlarged 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 and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying ▪ when first opening the tube, puncture foil seal with top end of cap ▪ 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":"20250512","id":"153cc033-00be-44f3-8462-3e460d8f4b1e","inactive_ingredient":["Inactive ingredients cetearyl alcohol, cetyl alcohol, glycerol monostearate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)"],"indications_and_usage":["Uses ▪ helps relieve local itching and discomfort associated with hemorrhoids ▪ temporarily shrinks hemorrhoidal tissue ▪ temporarily relieves burning ▪ aids in protecting irritated anorectal areas"],"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":{},"package_label_principal_display_panel":["Principal Display Panel - Carton Label NDC 49781-090-01 LEADER ® MAXIMUM STRENGTH Hemorrhoidal Cream Rapid soothing pain relief from burning, itching and discomfort Protects irritated tissue NET WT 1 OZ (28g) Principal Display Panel - Carton Label","Principal Display Panel - Tube Label NDC 49781-090-01 LEADER ® MAXIMUM STRENGTH Hemorrhoidal Cream Rapid soothing pain relief from burning, itching and discomfort Protects irritated tissue NET WT 1 OZ (28g) Principal Display Panel - Tube Label"],"purpose":["Purposes Protectant Protectant Vasoconstrictor Local anesthetic"],"set_id":"4e832b05-d3dc-4ffb-bdcc-9ffb983fbc08","spl_product_data_elements":["Leader Glycerin, Petrolatum, Phenylephrine Hydrochloride and Pramoxine Hydrochloride GLYCERIN GLYCERIN PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE PRAMOXINE HYDROCHLORIDE PRAMOXINE ALOE VERA LEAF CETOSTEARYL ALCOHOL CETYL ALCOHOL GLYCERYL MONOSTEARATE MINERAL OIL PEG-40 CASTOR OIL WATER PROPYLENE GLYCOL STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE"],"spl_unclassified_section":["Drug Facts","Other information ▪ store at 20° - 25°C (68°-77°F) ▪ for lot number and expiration date, see crimp of tube or see box"],"stop_use":["Stop use and ask a doctor if ▪ bleeding occurs ▪ condition gets worse or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use."],"version":"3","warnings":["Warnings For external use only Ask a doctor before use if you have ▪ heart disease ▪ high blood pressure ▪ diabetes ▪ thyroid disease ▪ trouble urinating due to an enlarged 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 exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if ▪ bleeding occurs ▪ condition gets worse or does not improve within 7 days 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 ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator"]}