{"active_ingredient":["Active Ingredients (in each suppository) Cocoa Butter 76% Zinc Oxide 10%"],"dosage_and_administration":["Directions adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product detach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppository insert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movement children under 12 years of age, consult a doctor"],"effective_time":"20251024","id":"41eb9348-e861-4ac7-e063-6294a90a96cf","inactive_ingredient":["Inactive ingredients Bismuth subgallate, glyceryl stearate, hydrogenated vegetable oil, methylparaben, propylparaben"],"indications_and_usage":["Uses gives temporary relief of burning, irritation, itching and discomfort associated with hemorrhoids temporarily provides a coating for for 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":["Calmol 4"],"generic_name":["ZINC OXIDE AND COCOA BUTTER"],"is_original_packager":[true],"manufacturer_name":["Resical Inc."],"package_ndc":["67492-104-11","67492-104-12","67492-104-13"],"product_ndc":["67492-104"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["1049137","1113714"],"spl_id":["41eb9348-e861-4ac7-e063-6294a90a96cf"],"spl_set_id":["5516f800-d3fa-4b90-a3eb-c0bdf3183b9b"],"substance_name":["ZINC OXIDE","COCOA BUTTER"],"unii":["SOI2LOH54Z","512OYT1CRR"]},"other_safety_information":["Other information store in a cool place not ober 80°F to avoid melting if subjected to higher temperatures, refrigeration may restore to a usable condition"],"package_label_principal_display_panel":["Calmol 4 Suppository 24 count CALMOL 24ct_R0625.p1.pdf Calmol 4 Hemorrhoidal Suppository 24 count Distributed by: Resical Inc. Orchard Park, New York 14127 The image below depicts a representative sample of packaging that is available. CALMOL 24CT_R0625.p1.jpg"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Protectant Astringent"],"questions":["Questions or comments? Call toll-free 1-800-204-6434 weekdays 9 AM to 5 PM EST"],"set_id":"5516f800-d3fa-4b90-a3eb-c0bdf3183b9b","spl_product_data_elements":["Calmol 4 Zinc Oxide and Cocoa Butter GLYCERYL MONOSTEARATE FAT, HARD METHYLPARABEN PROPYLPARABEN ZINC OXIDE ZINC OXIDE COCOA BUTTER COCOA BUTTER BISMUTH SUBGALLATE"],"stop_use":["Stop use and ask doctor if bleeding occurs or if condition worsens or does not improve within 7 days"],"version":"12","warnings":["Warnings For rectal use only When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask doctor if bleeding occurs or if condition worsens 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"]}