Acetic Acid

Acetic Acid OTIC SOLUTION, USP

Rx only

Acetic Acid 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.

Acetic Acid - 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 Acetic Acid

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.

Acetic Acid 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 is Acetic Acid 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 for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8180671

R5/08-R1

PRINCIPAL DISPLAY PANEL

 

Acetic Acid  Acetic Acid  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-7038 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetic Acid (Acetic Acid) Acetic Acid 0.02 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL DIACETATE   BENZETHONIUM CHLORIDE   SODIUM ACETATE   CITRIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-7038-41 15 mL In 1 BOTTLE None 2 0603-7038-45 30 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040607	02/24/2005

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 06/2011Qualitest Pharmaceuticals

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