{"active_ingredient":["Active Ingredient Phenol 1.4%"],"dosage_and_administration":["Directions Apply to the affected area (five sprays) Allow to remain in place for at least 15 seconds, then spit out. Use every 2 hours or as directed by a doctor or dentist. Children under 12 years of age should be supervised in the use of the product. Children under 3 years of age: Consult a dentist or doctor."],"effective_time":"20250722","id":"3a88920c-eeb8-7d71-e063-6294a90ac4af","inactive_ingredient":["Inactive ingredients citric acid, FD&C red #40, flavor, glycerin, propylene glycol, sodium citrate, saccharin sodium, water."],"indications_and_usage":["Uses for temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores."],"keep_out_of_reach_of_children":["Keep this and all drugs out of reach of children . In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Aseptil Rojo"],"generic_name":["PHENOL"],"is_original_packager":[true],"manufacturer_name":["Menper Distributors, Inc."],"package_ndc":["53145-004-01"],"product_ndc":["53145-004"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["3a88920c-eeb8-7d71-e063-6294a90ac4af"],"spl_set_id":["62c96dc1-4698-43c1-8e6d-f4062dc5eea2"],"substance_name":["PHENOL"],"unii":["339NCG44TV"],"upc":["0042279132013"]},"package_label_principal_display_panel":["image description"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional befre use."],"purpose":["Purpose Oral Analgesic/Anesthetic"],"questions":["Questions? call 1-800-560-5223 M-F 9 AM to 4 PM Eastern"],"set_id":"62c96dc1-4698-43c1-8e6d-f4062dc5eea2","spl_product_data_elements":["Aseptil Rojo Phenol CITRIC ACID ACETATE FD&C RED NO. 40 GLYCERIN SACCHARIN SODIUM PROPYLENE GLYCOL SODIUM CITRATE WATER PHENOL PHENOL"],"version":"6","warnings":["Warnings Sore throat warning: Sever or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor. When using this product do not use more thani directed 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 difficulty in breathing occurse"]}