acetic acid
Hi-Tech Pharmacal Co., Inc.

Acetic Acid Otic Solution, USP

ACETIC ACID- acetic acid solution 
Hi-Tech Pharmacal Co., Inc.

Acetic Acid Otic Solution, USP

1DESCRIPTION

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

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

2CLINICAL 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.

3INDICATIONS AND USAGE

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

4CONTRAINDICATIONS

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.

5WARNINGS

Discontinue promptly if sensitization or irritation occurs.

6PRECAUTIONS

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

7PEDIATRIC USE

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

8ADVERSE REACTIONS

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

9DOSAGE AND 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.

10HOW SUPPLIED

Acetic Acid Otic Solution, USP containing 2% acetic acid, is available in 15 mL (NDC 50383- 889-15) measured-drop, safety-tip plastic bottles.

11STORAGE

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

12PRINCIPAL DISPLAY PANEL

Image of Container Label - 15 mL

13PRINCIPAL DISPLAY PANEL

Image of Carton - 15 mL

ACETIC ACID 
acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50383-889
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETIC ACID (ACETIC ACID) ACETIC ACID 20.65 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
BENZETHONIUM CHLORIDE  
PROPYLENE GLYCOL DIACETATE  
SODIUM ACETATE  
Packaging
# Item Code Package Description
1 NDC:50383-889-15 1 in 1 BOX
1 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012179 01/22/2010
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 01/2010
 
Hi-Tech Pharmacal Co., Inc.

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