Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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; PRINCIPAL DISPLAY PANEL Acetic Acid Otic Solution, USP 2% - NDC 62135-801-51 - 15 mL Bottle Label image description
- HOW SUPPLIED 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
- PRINCIPAL DISPLAY PANEL Acetic Acid Otic Solution, USP 2% - NDC 62135-801-51 - 15 mL Bottle Label image description
Overview
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 contain citric acid anhydrous. 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. image description
Indications & Usage
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.
Dosage & 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 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.
Warnings & Precautions
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.
Adverse Reactions
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Storage & Handling
RECOMMENDED STORAGE 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
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