Acetic Acid

Generic Name: acetic acid

Over-the-Counter (OTC)

Brand Names:

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%), sodium acetate (0.015%), and citric acid. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic acid otic solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure

Overview

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%), sodium acetate (0.015%), and citric acid. The molecular formula for acetic acid is CH 3 COOH, with a molecular weight of 60.05. The structural formula is: Acetic acid otic solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal. Chemical Structure

Uses

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

Dosage

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 a 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 3 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal.

Side Effects

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 1­800-FDA-1088 or www.fda.gov/medwatch.

Warnings

WARNINGS Discontinue promptly if sensitization or irritation occurs. CONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

Storage

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

Frequently Asked Questions

What is Acetic Acid used for?

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

What are the side effects of Acetic Acid?

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 1­800-FDA-1088 or www.fda.gov/medwatch.

What are the important warnings for Acetic Acid?

WARNINGS Discontinue promptly if sensitization or irritation occurs. CONTRAINDICATIONS Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.