acetic acid (Acetic Acid)  solution 
[Vintage Pharmaceuticals, LLC]

Rx Only

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 empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

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

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

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

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.

WARNINGS

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

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.

ADVERSE REACTIONS

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

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 to 5 drops of Acetic Acid Otic 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.

HOW SUPPLIED

Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.

STORAGE

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured by:
VINTAGE PHARMACEUTICALS, LLC
Huntsville, AL 35811

8180671
R3/05-R0

Acetic Acid (Acetic Acid)

PRODUCT INFO Product Code 0254-9015 Dosage Form SOLUTION Route Of Administration AURICULAR (OTIC) DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Acetic Acid (Acetic Acid) Active 0.02 MILLILITER  In 1 MILLILITER benzethonium chloride Inactive   citric acid Inactive   propylene glycol diacetate Inactive   sodium acetate Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0254-9015-43 15 MILLILITER In 1 BOTTLE None 2 0254-9015-45 30 MILLILITER In 1 BOTTLE None

Revised: 01/2007