Vosol

acetic acid

Dosage Form: otic solution
VōSoL®

Otic Solution

(Acetic acid otic solution, USP)

Rx only

Vosol Description

VōSoL (Acetic acid otic solution, USP) is a solution containing 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:

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

Vosol - 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 Vosol

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

Contraindications

Hypersensitivity to VōSoL 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.

Vosol Dosage and Administration

Carefully remove all cerumen and debris to allow VōSoL to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with VōSoL 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 VōSoL every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of VōSoL 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 Vosol Supplied

VōSoL (Acetic acid otic solution, USP), containing acetic acid (2%), is available in 15 mL, measured-drop, safety-tip plastic bottles (NDC 0095-0202-15).

STORAGE

Store at 20°-25°C (68°-77°F).

Keep container tightly closed.

Rx Only

Manufactured For:

ECR Pharmaceuticals Co., Inc.

Richmond, Virginia 23255

Rev. 889:00 11/09

MG# 28567

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0095-0202-15

15 mL

VōSoL®

Otic Solution

(Acetic acid otic solution, USP)

VōSoL is a nonaqueous solution containing acetic acid (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%).

Rx Only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0095-0202-15

15 mL

VōSoL®

Otic Solution

(Acetic acid otic solution, USP)

Rx Only

Vosol  acetic acid  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0095-0202 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0095-0202-15 1 BOTTLE In 1 CARTON contains a BOTTLE 1 15 mL In 1 BOTTLE This package is contained within the CARTON (0095-0202-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012179	03/15/2010

Labeler - ECR Pharmaceuticals Co., Inc. (831116350)

Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)

Establishment
Name	Address	ID/FEI	Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE

Revised: 10/2010ECR Pharmaceuticals Co., Inc.

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