{"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 1-­800-FDA-1088 or www.fda.gov/medwatch ."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; 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 Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal."],"description":["DESCRIPTION: Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are: Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure_Hydrocortisone"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and 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 Hydrocortisone and 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 Hydrocortisone and 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":"20250425","how_supplied":["HOW SUPPLIED: Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 71656-064-10)."],"id":"339e0417-4d1a-e168-e063-6294a90a50bb","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, complicated by inflammation."],"openfda":{"application_number":["NDA012770"],"brand_name":["hydrocortisone and acetic acid"],"generic_name":["HYDROCORTISONE AND ACETIC ACID OTIC"],"is_original_packager":[true],"manufacturer_name":["Saptalis Pharmaceuticals, LLC"],"nui":["N0000175576","N0000175450"],"package_ndc":["71656-064-10"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["71656-064"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["313786"],"spl_id":["339e0417-4d1a-e168-e063-6294a90a50bb"],"spl_set_id":["d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32"],"substance_name":["ACETIC ACID","HYDROCORTISONE"],"unii":["Q40Q9N063P","WI4X0X7BPJ"]},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Label","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Carton"],"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":"d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32","spl_product_data_elements":["hydrocortisone and acetic acid hydrocortisone and acetic acid otic BENZETHONIUM CHLORIDE PROPYLENE GLYCOL PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ACETIC ACID ACETIC ACID HYDROCORTISONE HYDROCORTISONE ANHYDROUS CITRIC ACID"],"spl_unclassified_section":["STORAGE: Store at room temperature, 20°C to 25°C (68°F to 77°F). Keep container tightly closed. Rx only Distributed by: Saptalis Pharmaceuticals, LLC. Hauppauge, NY 11788 MADE IN USA May 2024-R3 PPM-0082"],"version":"3","warnings":["WARNINGS: Discontinue promptly if sensitization or irritation occurs."]}