Acetic Acid

Bausch & Lomb Incorporated

Acetic Acid 2% in AqueousAluminum Acetate Otic Solution

FULL PRESCRIBING INFORMATION: CONTENTS*

• ACETIC ACID DESCRIPTION
• CLINICAL PHARMACOLOGY
• ACETIC ACID INDICATIONS AND USAGE
• ACETIC ACID CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
• ACETIC ACID ADVERSE REACTIONS
• OVERDOSAGE
• ACETIC ACID DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Storage:
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Rx only

FOR USE IN THE EARS ONLY

NOT FOR USE IN THE EYES

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, Sodium Hydroxide and Purified Water. Sodium Hydroxide and/or Glacial Acetic Acid may be added to adjust the pH (3.5 to 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

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.

ACETIC ACID INDICATIONS AND USAGE

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

ACETIC ACID 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.

ACETIC ACID ADVERSE REACTIONS

Irritation may occur.

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 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: November 2012

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

9066902 Folded

9274302 Flat

Principal Display Panel

NDC 24208-615-77

Bausch & Lomb

Acetic Acid 2%
in Aqueous

Aluminum

Acetate Otic

Solution

(Sterile)

Rx only

[icon-ear]

USE IN EARS ONLY

CAUTION: NOT FOR OPHTHALMIC USE

60 mL