{"adverse_reactions":["ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Acetic acid is anti-bacterial and anti-fungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal."],"description":["DESCRIPTION Acetic Acid Otic Solution USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal."],"effective_time":"20221211","how_supplied":["HOW SUPPLIED Product: 50090-6263 NDC: 50090-6263-0 15 mL in a BOTTLE / 1 in a CARTON"],"id":"d4f3cc40-e192-40ae-99e6-09855e23710b","indications_and_usage":["INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial."],"openfda":{},"package_label_principal_display_panel":["ACETIC ACID Label Image"],"pediatric_use":["PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established."],"precautions":["PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear. PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established."],"set_id":"c13697a4-1b1d-4cae-a42e-1e87a92f82e1","spl_product_data_elements":["Acetic Acid Acetic Acid ACETIC ACID ACETIC ACID PROPYLENE GLYCOL DIACETATE BENZETHONIUM CHLORIDE SODIUM ACETATE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL"],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] KEEP CONTAINER TIGHTLY CLOSED Rx Only Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Rev. 05/2018 MADE IN USA Rev. 12/2018"],"version":"1","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}