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Acetic Acid

Dosage Form: otic solution

Rx only

FOR USE IN THE EARS ONLY

Acetic Acid Description

Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution contains Acetic Acid 2% as the active ingredient, in a solution containing aluminum acetate (formed from Aluminum Sulfate, Calcium Carbonate, Glacial Acetic Acid), Boric Acid, Purified Water and Sodium Hydroxide. Sodium Hydroxide and/or Glacial Acetic Acid may be added to adjust the pH (3.5-5.0). Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is instilled in the external auditory canal. Acetic Acid is an astringent and antimicrobial agent.

Chemically, Acetic Acid is C2H4O2 and has the following structural formula:

Molecular weight: 60.05

Acetic Acid - Clinical Pharmacology

Acetic Acid is antibacterial and antifungal and is effective against microorganisms (bacteria and fungi) that infect the ears of patients with acute diffuse external otitis. In vitro tests, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% Acetic Acid. Quantitative absorption of Acetic Acid 2% from external auditory canal is not known.

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 or any of the ingredients in this product. Perforated tympanic membranes is considered a contraindication to the use of any external ear canal medication.

Warnings

Avoid use or use with caution in patients with perforated tympanic membrane (see CONTRAINDICATIONS).

Precautions

General

Care should be taken to assure that the Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution gets into the ear canal and stays in contact with the affected area long enough for the drug to act.

Discontinue promptly if sensitization or irritation occurs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic potential of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.

Adverse Reactions

Irritation may occur.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

No toxic effect has been reported with overdosage of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.

Acetic Acid Dosage and Administration

The patient should lie on the side with the affected ear uppermost. Instill 4 to 6 drops into the external auditory canal and maintain this position for 5 minutes. Repeat the procedure every 2 to 3 hours.

How is Acetic Acid Supplied

Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is available in 60 mL plastic squeeze bottle with otic tip.

NDC 24208-615-77

Storage:

Store between 15˚- 25˚ C (59˚-77˚ F).

PROTECT FROM FREEZING.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: May 2016

Bausch + Lomb, a division of Valeant Pharmaceuticals North America, LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

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NDC 24208-615-77

Acetic Acid 2%
in Aqueous
Aluminum
Acetate Otic
Solution
(Sterile)

FOR USE IN
EARS ONLY

Rx only

60 mL

BAUSCH + LOMB

Acetic Acid 
Acetic Acid solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-615
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetic Acid (Acetic Acid) Acetic Acid 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM SULFATE  
BORIC ACID  
CALCIUM CARBONATE  
WATER  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:24208-615-77 1 BOTTLE, PLASTIC in 1 CARTON
1 60 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040063 02/25/1994
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-615)
Revised: 05/2016
 
Bausch & Lomb Incorporated

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