Vosol

Generic Name: 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:

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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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:0095-0202-15 1 BOTTLE (BOTTLE) in 1 CARTON
1 15 mL in 1 BOTTLE
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: 10/2010
 
ECR Pharmaceuticals Co., Inc.

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