ADVERSE REACTIONS SECTION.

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 SECTION.

CLINICAL PHARMACOLOGY Acetic acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides low surface tension; benzethonium chloride is surface active agent that promotes contact of the solution with tissues.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered contraindication to the use of any medication in the external ear canal.

DESCRIPTION SECTION.

DESCRIPTION Acetic acid otic solution, USP is solution of acetic acid (2%), in 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 CH3COOH, with molecular weight of 60.05. The structural formula is:Acetic acid otic solution, USP is available as nonaqueous otic solution buffered at pH for use in the external ear canal.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

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 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 drops to drops of acetic acid otic solution every hours to hours. The wick may be removed after 24 hours but the patient should continue to instill drops of acetic acid otic solution times or times daily thereafter, for as long as indicated. In pediatric patients, drops to drops may be sufficient due to the smaller capacity of the ear canal.

HOW SUPPLIED SECTION.

HOW SUPPLIED Acetic acid otic solution, USP, containing 2% acetic acid, is available in 15 mL measured-drop, safety-tip plastic bottles. NDC 52817-816-15 15 mL Bottle.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL. NDC 52817-816-15Acetic Acid Otic SolutionUSP, 2%Rx only 15 mL. Label.

PEDIATRIC USE SECTION.

PEDIATRIC USE Safety and effectiveness in pediatric patients below the age of years have not been established.

PRECAUTIONS SECTION.

PRECAUTIONS Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

STORAGE AND HANDLING SECTION.

STORAGE Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Keep container tightly closed.Manufactured by:Saptalis Pharmaceuticals, LLCHauppauge, NY 11788Distributed by:TruPharma, LLCTampa, FL 33609Rev. 03/20-R1.

WARNINGS SECTION.

WARNINGS Discontinue promptly if sensitization or irritation occurs.