{"active_ingredient":["Active ingredient Menthol 2%"],"do_not_use":["Do not use this product for more than 7 days unless directed by a dentist or doctor."],"dosage_and_administration":["Directions Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal. Children under 12 years of age should be supervised in use of this product. Children under 12 years of age: Consult a dentist or doctor."],"effective_time":"20231208","id":"0c06e3d2-4481-f4b5-e063-6394a90a0608","inactive_ingredient":["Inactive ingredients Clove oil, glycerin, guaiacol, oregano oil, peppermint oil."],"indications_and_usage":["Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["ORCA Complete Menthol Pain Reliever"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["ORCA Products, LLC"],"package_ndc":["82939-000-01","82939-000-02"],"product_ndc":["82939-000"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2611702"],"spl_id":["0c06e3d2-4481-f4b5-e063-6394a90a0608"],"spl_set_id":["99990e27-d66b-4d61-97f2-6a76066eb8b8"],"substance_name":["MENTHOL, UNSPECIFIED FORM"],"unii":["L7T10EIP3A"],"upc":["0860003109939"]},"other_safety_information":["Other information Do not use if tamperproof seal is not intact at time of first use."],"package_label_principal_display_panel":["Package Labeling: 82939-000-02 Label Print Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose oral pain reliever"],"questions":["Questions? 1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)"],"set_id":"99990e27-d66b-4d61-97f2-6a76066eb8b8","spl_product_data_elements":["ORCA Complete Menthol Pain Reliever MENTHOL CLOVE OIL GLYCERIN GUAIACOL OREGANO LEAF OIL PEPPERMINT OIL MENTHOL, UNSPECIFIED FORM MENTHOL"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"version":"3","warnings":["Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor. When using this product do not exceed recommended dosage. Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away."],"when_using":["When using this product do not exceed recommended dosage."]}