PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package Label Principal Display. NDC 55045-1243-00. NDC 55045-1243-00.

PRECAUTIONS SECTION.

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

SPL UNCLASSIFIED SECTION.

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

WARNINGS SECTION.

WARNINGS. Discontinue promptly if sensitization or irritation occurs.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

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 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%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with molecular weight of 60.05. The structural formula is:Acetic Acid is available as nonaqueous otic solution buffered at pH for use in the external ear canal.. Acetic Acid.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Carefully remove all cerumen and debris to allow Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert wick of cotton saturated with 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 to drops of Acetic Acid every to hours. The wick may be removed after 24 hours but the patient should continue to instill drops of Acetic Acid or times daily thereafter, for as long as indicated. In pediatric patients, 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 (NDC 55045-1243-00) measured-drop, safety-tip plastic bottles.

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.