Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL NDC 68071-1739-5 measured-drop, safety-tip plastic bottles.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP
- HOW SUPPLIED Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL NDC 68071-1739-5 measured-drop, safety-tip plastic bottles.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL PDP
Overview
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 CH 3 COOH, 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. Chemical Structure
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 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.
Warnings & Precautions
WARNINGS Discontinue promptly if sensitization or irritation occurs.
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.
Adverse Reactions
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
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