The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Acetic Acid (NDC 21695-222). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, pediatric use, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 (A8c12387 4b2b 49c2 B9c5 112ffb133950 01)
Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
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.
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 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.
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 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.
Acetic Acid Otic Solution, USP containing 2% acetic acid, is available in 15 mL (NDC 21695-222-15) measured-drop, safety-tip plastic bottles.
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
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Acetic Acid 2% (A8c12387 4b2b 49c2 B9c5 112ffb133950 02)
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