Acetic Acid Otic Solution, USP

Acetic Acid Otic Solution, USP

Drug Labeling and Warnings

Drug Details

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ACETIC ACID- acetic acid solution 
Preferred Pharmaceuticals Inc.

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Acetic Acid Otic Solution, USP

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%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

Chemical Structure

Acetic Acid 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 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 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.

HOW SUPPLIED

Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL (NDC: 68788-7231-1) measured-drop, safety-tip plastic bottles.

STORAGE

Store at 20°- 25°C (68°-77°F). Keep container tightly closed.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 889:02 11/09

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Acetic Acid Solution 2 perecent

NDC: 68788-7231-1

Acetic Acid Otic Solution, USP

15 mL

Rx only

ACETIC ACID 
acetic acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68788-7231(NDC: 50383-889)
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID20.65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
SODIUM ACETATE (UNII: 4550K0SC9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-7231-11 in 1 BOX08/06/2018
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01217908/06/2018
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7231)

Revised: 5/2019
 
Preferred Pharmaceuticals Inc.


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