ACETIC ACID OTIC SOLUTION, USP

Acetic Acid Otic Solution, USP is a colorless to pale yellow color nonaqueous solution of glacial acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride, propylene glycol diacetate, and sodium acetate trihydrate. It may also containcitric acid anhydrous.

The molecular formula for acetic acid is CH ₃COOH, with a molecular weight of 60.05. The structural formula is:

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

Acetic acid is anti-bacterial and anti-fungal; 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.

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

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.

Discontinue promptly if sensitization or irritation occurs.

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.

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

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 the 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 to 5 drops of the solution 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 otic solution 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.

Acetic Acid Otic Solution, USP, 2% is a colorless to pale yellow color solution supplied in 15 mL bottle with dropper plug and extended TIP closure.

They are available as follows:

Bottle of 15 mL – NDC 62135-801-51

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

KEEP CONTAINER TIGHTLY CLOSED

Rx Only

Manufactured for:

Chartwell RX, LLC.

Congers, NY 10920

L71805

Rev: 03/2024

Acetic Acid Otic Solution, USP 2% - NDC 62135-801-51 - 15 mL Bottle Label

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