{"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; hydrocortisone is anti-inflammatory, 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 Otic Solution 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 propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid. The empirical formulas for acetic acid and hydrocortisone are CH 3 COOH and C 21 H 30 O 5 , with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are: Hydrocortisone and Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. This is an image of the structural formulas of hydrocortisone and acetic acid."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and 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 to 5 drops of Hydrocortisone and Acetic Acid Otic Solution 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 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":"20090915","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. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed."],"id":"61e2f6d3-ed4b-48a4-abac-d29de8392879","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL This is an image of the label for Hydrocortisone and Acetic Acid Otic Solution."],"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":"adfc6013-ec78-4225-b88b-2b4aa9fd8e1f","spl_product_data_elements":["Hydrocortisone and Acetic Acid hydrocortisone and acetic acid HYDROCORTISONE HYDROCORTISONE ACETIC ACID ACETIC ACID PROPYLENE GLYCOL DIACETATE BENZETHONIUM CHLORIDE SODIUM ACETATE CITRIC ACID MONOHYDRATE"],"spl_unclassified_section":["Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8180670 R11/07-R1"],"storage_and_handling":["STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed."],"version":"5","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}