acetic acid

Hi-Tech Pharmacal Co., Inc.

Acetic Acid Otic Solution, USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACETIC ACID DESCRIPTION
• CLINICAL PHARMACOLOGY
• ACETIC ACID INDICATIONS AND USAGE
• ACETIC ACID CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• PEDIATRIC USE
• ACETIC ACID ADVERSE REACTIONS
• ACETIC ACID DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

ACETIC ACID DESCRIPTION

Acetic Acid Otic Solution, USP is a solution of 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 CH₃COOH, with a molecular weight of 60.05. The structural formula is:

Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

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.

ACETIC ACID INDICATIONS AND USAGE

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

ACETIC ACID CONTRAINDICATIONS

Hypersensitivity to Acetic Acid or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

Discontinue promptly if sensitization or irritation occurs.

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.

ACETIC ACID ADVERSE REACTIONS

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

ACETIC ACID DOSAGE AND ADMINISTRATION

Carefully remove all cerumen and debris to allow Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a 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 3 to 5 drops of 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 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.

HOW SUPPLIED

Acetic Acid Otic Solution, USP containing 2% acetic acid, is available in 15 mL (NDC 50383- 889-15) measured-drop, safety-tip plastic bottles.

STORAGE

Store at 20°- 25°C (68°-77°F). Keep container tightly closed.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

MG# 28428

Rev. 889:02 11/09

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL