{"active_ingredient":["Active ingredient Menthol 0.45% Zinc Oxide 20%"],"dosage_and_administration":["Directions • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of the product. • Children under 12 years of age: consult a doctor. • Apply externally to the affected area up to 6 times daily."],"effective_time":"20241115","id":"6a1b3823-7b1f-4c28-b74d-889ccd7b3703","inactive_ingredient":["Inactive ingredients Calamine, Cod Liver Oil, Disodium EDTA, Lanolin, Methylparaben, Microcrystalline Wax, Mineral Oil, Petrolatum, Propylparaben, Sodium Borate, Sorbitan Sesquioleate, Talc, Water (Purified)"],"indications_and_usage":["Uses A multipurpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks, lower abdomen and inner thigh due to moisture, occlusion, chafing or continued contact with urine or feces. Helps relieve the local itching, discomfort, pain, burning and irritation associated with anorectal disorders and hemorrhoids. May provide a cooling sensation."],"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":{},"other_safety_information":["Other information Store at controlled room temperature 20° - 25°C (68° - 77°F)"],"package_label_principal_display_panel":["Principal Display Panel Rugby® Compare to the active ingredients in Calmoseptine® Ointment* NDC 0536-1204-73 Menthol Zinc Ointment Anorectal Ointment • Zinc Oxide 20% • Menthol 0.45% NET WT. 1113 g (4 oz.) 0.45%/20% carton"],"purpose":["Purpose External Analgesic Astringent"],"questions":["Questions or comments? (800) 645-2158"],"set_id":"5797b7b0-d5b2-41da-9825-245cc9b6f348","spl_product_data_elements":["Rugby Barrier Cream Barrier Cream ZINC OXIDE ZINC OXIDE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM FERRIC OXIDE RED COD LIVER OIL DISODIUM ETHYLENEDIAMINEDIACETATE LANOLIN METHYLPARABEN MICROCRYSTALLINE WAX MINERAL OIL PETROLATUM PROPYLPARABEN SODIUM BORATE SORBITAN SESQUIOLEATE TALC WATER"],"spl_unclassified_section":["Drug Facts","This product is not manufactured or distributed by Calmoseptine, Inc., the distributor of Calmoseptine® Ointment. KEEP CARTON FOR COMPLETE DRUG FACTS. Dist. By Rugby Laboratories 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA Re-Order No.: 370661 Rev. 08/19 R-101"],"spl_unclassified_section_table":["<table styleCode=\"Noautorules\" width=\"100%\"><col width=\"33%\"/><col width=\"33%\"/><col width=\"33%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Re-Order No.: 370661</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>Rev. 08/19</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph>R-101</paragraph></td></tr></tbody></table>"],"stop_use":["Stop use and consult a doctor in case of bleeding Do not exceed recommended daily dosage unless directed by a doctor. • if condition worsens or does not improve within 7 days. Do not put product into rectum by using fingers or any mechanical device or applicator Allergy Alert: Certain persons can develop allergic reactions to this product. If the symptoms being treated does not subside or if redness, ittitation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor."],"version":"2","warnings":["Warnings For external use only Stop use and consult a doctor in case of bleeding Do not exceed recommended daily dosage unless directed by a doctor. • if condition worsens or does not improve within 7 days. Do not put product into rectum by using fingers or any mechanical device or applicator Allergy Alert: Certain persons can develop allergic reactions to this product. If the symptoms being treated does not subside or if redness, ittitation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}