{"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 VōSoL 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 VōSoL (Acetic acid otic solution, USP) is a solution containing 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: VōSoL is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Acetic Acid Structural Formula"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow VōSoL to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with VōSoL 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 VōSoL every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of VōSoL 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":"20101014","how_supplied":["HOW SUPPLIED VōSoL (Acetic acid otic solution, USP), containing acetic acid (2%), is available in 15 mL, measured-drop, safety-tip plastic bottles (NDC 0095-0202-15)."],"id":"a1606d21-8a14-41fd-9e89-7512835ff995","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 0095-0202-15 15 mL VōSoL ® Otic Solution (Acetic acid otic solution, USP) VōSoL is a nonaqueous solution containing acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). Rx Only Image of Container Label - 15 mL","PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0095-0202-15 15 mL VōSoL ® Otic Solution (Acetic acid otic solution, USP) Rx Only Image of Carton - 15 mL"],"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":"39de0239-a4f6-45b0-a3cf-c6fba941c08e","spl_product_data_elements":["VoSoL acetic acid ACETIC ACID ACETIC ACID PROPYLENE GLYCOL BENZETHONIUM CHLORIDE PROPYLENE GLYCOL DIACETATE SODIUM ACETATE"],"spl_unclassified_section":["Rx only"],"storage_and_handling":["STORAGE Store at 20°-25°C (68°-77°F). Keep container tightly closed. Rx Only Manufactured For: ECR Pharmaceuticals Co., Inc. Richmond, Virginia 23255 Rev. 889:00 11/09 MG# 28567"],"version":"2","warnings":["WARNINGS Discontinue promptly if sensitization or irritation occurs."]}