{"adverse_reactions":["ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; 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 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 solution of acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow acetic acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid 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 acetic acid 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 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":"20250910","how_supplied":["HOW SUPPLIED Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC 50383-889-15) measured-drop, safety-tip plastic bottles."],"id":"68c0b983-a676-4ef0-ab06-c3670794edbe","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":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 50383-889-15 Acetic Acid Otic Solution, USP 15 mL Rx only carton"],"precautions":["PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear."],"set_id":"c53fc11e-b177-446e-839d-391e1b2eacff","spl_product_data_elements":["Acetic Acid Acetic Acid ACETIC ACID ACETIC ACID PROPYLENE GLYCOL BENZETHONIUM CHLORIDE PROPYLENE GLYCOL DIACETATE SODIUM ACETATE"],"spl_unclassified_section":["Rx only","PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of 3 years have not been established.","STORAGE Store at 20°- 25°C (68°-77°F). Keep container tightly closed. Distributed by: Akorn Operating Company LLC Gurnee, IL 60031 Rev. 889:04 07/22"],"version":"9","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}