{"active_ingredient":["Active ingredients Purposes Pramoxine hydrochloride 1% Local anesthetic Zinc oxide 5% Astringent"],"active_ingredient_table":["<table width=\"55%\"><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purposes</content></th></tr></thead><tbody><tr><td>Pramoxine hydrochloride 1%</td><td>Local anesthetic</td></tr><tr><td>Zinc oxide 5%</td><td>Astringent </td></tr></tbody></table>"],"dosage_and_administration":["Directions Adults and children 12 years of age and older: Apply externally to the affected area up to 5 times daily. When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or cleanse by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue before application of this product. To use applicator: Remove cap from tube and attach applicator. Gently squeeze tube to apply: do not insert applicator into rectum. Thoroughly cleanse applicator after use. Children under 12 years of age: consult a doctor."],"effective_time":"20230105","id":"f18b44ea-5d2e-6043-e053-2a95a90afbac","inactive_ingredient":["Inactive ingredients beeswax, cetyl alcohol, cetyl esthers wax, glycerin, methylparaben, propylparaben, sodium lauryl sulfate, USP water"],"indications_and_usage":["Uses temporarily relieves pain, itching, burning and soreness associated with hemorrhoids."],"keep_out_of_reach_of_children":["Keep out of the reach of children , If swallowed, get medical help or call a Poison Control Center right away"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 28 g Tube Carton NDC 11868-390-48 Tronolane ® Anesthetic Cream for Hemorrhoids DUAL-ACTION FORMULA Rapid Relief of Pain & Itching Odor-free • Non-greasy • Non-staining 1 OZ (28 g) PRINCIPAL DISPLAY PANEL - 28 g Tube Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients Purposes Pramoxine hydrochloride 1% Local anesthetic Zinc oxide 5% Astringent"],"purpose_table":["<table width=\"55%\"><col width=\"60%\" align=\"left\" valign=\"middle\"/><col width=\"40%\" align=\"right\" valign=\"middle\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purposes</content></th></tr></thead><tbody><tr><td>Pramoxine hydrochloride 1%</td><td>Local anesthetic</td></tr><tr><td>Zinc oxide 5%</td><td>Astringent </td></tr></tbody></table>"],"set_id":"0d5ba4f1-1178-490d-8524-143d0aa2f0ef","spl_product_data_elements":["Tronolane Pramoxine HCl YELLOW WAX CETYL ALCOHOL CETYL ESTERS WAX GLYCERIN METHYLPARABEN PROPYLPARABEN SODIUM LAURYL SULFATE WATER PRAMOXINE HYDROCHLORIDE PRAMOXINE ZINC OXIDE ZINC CATION"],"spl_unclassified_section":["Drug Facts","Distributed by : New Genesis / Monticello Drug LLC Jacksonville, FL 32207"],"stop_use":["Stop use and ask a doctor if : bleeding occurs condition worsens or does not improve within 7 days"],"storage_and_handling":["Other information For your protection, do not use if glue end carton or seal under cap is broken."],"version":"7","warnings":["Warnings For external use only. Certain persons can develop allergic reactions to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. If pregnant or breast-feeding, ask a health professional before use. When using this product, do not exceed the recommended daily dose, unless directed by a doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if : bleeding occurs condition worsens or does not improve within 7 days Keep out of the reach of children , If swallowed, get medical help or call a Poison Control Center right away"],"when_using":["When using this product, do not exceed the recommended daily dose, unless directed by a doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator."]}