{"adverse_reactions":["ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1­800-FDA-1088 or www.fda.gov/medwatch."],"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 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 solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. 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, USP 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 otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic 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 drops to 5 drops of acetic acid otic solution every 4 hours 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 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal."],"effective_time":"20250210","how_supplied":["HOW SUPPLIED Acetic acid otic solution, USP, containing 2% acetic acid, is available in 15 mL measured‑drop, safety-tip plastic bottles. NDC 68071-2984-5 15 mL Bottle"],"id":"2dcdd631-b9c5-e301-e063-6294a90a038f","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":{"application_number":["ANDA040607"],"brand_name":["Acetic Acid"],"generic_name":["ACETIC ACID"],"manufacturer_name":["NuCare Pharmaceuticals,Inc."],"original_packager_product_ndc":["52817-816"],"package_ndc":["68071-2984-5"],"product_ndc":["68071-2984"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["197305"],"spl_id":["2dcdd631-b9c5-e301-e063-6294a90a038f"],"spl_set_id":["f9b4d18b-25f3-604f-e053-6394a90a5531"],"substance_name":["ACETIC ACID"],"unii":["Q40Q9N063P"],"upc":["0368071298451"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL pdp"],"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."],"set_id":"f9b4d18b-25f3-604f-e053-6394a90a5531","spl_product_data_elements":["Acetic Acid Acetic Acid PROPYLENE GLYCOL BENZETHONIUM CHLORIDE PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ANHYDROUS CITRIC ACID ACETIC ACID ACETIC ACID"],"spl_unclassified_section":["Rx only"],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Manufactured by: Saptalis Pharmaceuticals, LLC Hauppauge, NY 11788 Distributed by: TruPharma, LLC Tampa, FL 33609 Rev. 03/20-R1"],"version":"2","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}