{"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. Acetic Acid"],"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":"20130712","how_supplied":["HOW SUPPLIED Acetic Acid Otic Solution, USP containing 2% acetic acid, is available in 15 mL (NDC 55045-1243-00) measured-drop, safety-tip plastic bottles."],"id":"e0f01554-43e3-4ed2-afef-d9fa4f539e54","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 NDC 55045-1243-00 NDC 55045-1243-00"],"precautions":["PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear."],"set_id":"53d97ebe-fdf0-47af-ba93-a4a3327981de","spl_product_data_elements":["acetic acid acetic acid PROPYLENE GLYCOL BENZETHONIUM CHLORIDE PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ACETIC ACID ACETIC ACID"],"spl_unclassified_section":["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. Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 MG# 28428 Rev. 889:02 11/09"],"version":"2","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}