{"active_ingredient":["Active ingredients Benzocaine .............................2% Menthol ................................0.5% Cetylpyridinium Chloride ........0.1%"],"dosage_and_administration":["Directions: adults and children 2 years of age or older: Spray Actisep several times to affected area in mouth or lips. Do not use more than 4 times a day. children between 2 and 12 years of age: should be supervised in the use of this product. children under 2 years of age: do not use As a gargle or mouthwash, Adults and Children 12 years and over, place ½ teaspoon (2.5 mL) in ½ glass of warm water several times a day. Do not use more than 4 times a day."],"dosage_and_administration_table":["<table width=\"80%\"><caption/><tbody><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">adults and children 2 years of age or older:</td><td styleCode=\"Botrule Rrule Toprule\">Spray Actisep several times to affected area in mouth or lips. Do not use more than 4 times a day.</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">children between 2 and 12 years of age:</td><td styleCode=\"Botrule Rrule Toprule\">should be supervised in the use of this product.</td></tr><tr><td styleCode=\"Botrule Lrule Rrule Toprule\">children under 2 years of age:</td><td styleCode=\"Botrule Rrule Toprule\">do not use</td></tr></tbody></table>"],"effective_time":"20240628","id":"ee35a70b-42ad-4819-80f5-988e816d6d86","inactive_ingredient":["Inactive ingredients: Castor oil, methylparaben, propylparaben, propylene glycol, purified water, sucralose."],"indications_and_usage":["Uses: • For temporary relief of occasional minor sore throat pain and dry, scratchy throat. • For the temporary relief of pain associated with canker sores, minor irritation or injury of the mouth and gums, minor dental procedures, minor irritations caused by dentures or orthodontic appliances."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Packaging Antisep solution"],"purpose":["Purposes Oral Anesthetic Oral Anesthetic Oral Antiseptic"],"questions":["Questions or comments? (787) 608-0882"],"set_id":"092c246f-db0e-4250-8245-a6799e793026","spl_product_data_elements":["ACTISEP BENZOCAINE, MENTHOL, CETYLPYRIDINIUM CHLORIDE BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM CASTOR OIL METHYLPARABEN PROPYLPARABEN PROPYLENE GLYCOL WATER SUCRALOSE"],"spl_unclassified_section":["Drug Facts","Contains the same active ingredients as Orasep® Solution* ANTISEPTIC • ANESTHETIC Alcohol Free Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646 *Orasep® Solution is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp."],"storage_and_handling":["Other information: Tamper Evident Feature: Do not use if heat seal under cap is torn, broken or missing. Store at controlled room temperature 15-30°C (59-86°F)."],"version":"3","warnings":["Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert : do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persist or worsens, see your dentist or doctor promptly. Do not exceed recommended dosage. Do not use in or near eyes for teething in children under 2 years of age If pregnant or breast feeding, ask a health professional before use. In the event of accidental contact with eyes, flush immediately with water and continuously for 10 minutes. Seek immediate medical attention if pain persists. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}