Acetic Acid

Name: Acetic Acid

Stability

Storage

Irrigation

Solution for Irrigation

20–25°C2 3 4 (may be exposed briefly to temperatures up to 40°C).2 3 Avoid excessive heat; do not warm >66°C.1 2 3 4 Do not freeze.1 2 4

Use immediately after opening; discard unused portion.1 2 3 4

Acetic Acid - Clinical Pharmacology

Acetic Acid is anti-bacterial and anti-fungal; 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.

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.

How is Acetic Acid Supplied

Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles.

RECOMMENDED STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

KEEP CONTAINER TIGHTLY CLOSED

Rx Only

Product No.: 8741

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc

Morton Grove, IL 60053

A50-8741-15

REV. 09-12

Principal display panel

MGP

NDC 60432-741-15

Acetic Acid

OTIC

SOLUTION

USP, 2%

DO NOT USE IF BAND

PRINTED "SEALED FOR YOUR

PROTECTION" AROUND CAP

IS BROKEN OR MISSING.

Rx Only

NET CONTENTS:

15 mL

Acetic Acid 
Acetic Acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60432-741
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetic Acid (Acetic Acid) Acetic Acid 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
PROPYLENE GLYCOL DIACETATE  
BENZETHONIUM CHLORIDE  
SODIUM ACETATE  
ANHYDROUS CITRIC ACID  
Packaging
# Item Code Package Description
1 NDC:60432-741-15 15 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040166 07/26/1996
Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant - Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS(60432-741), LABEL(60432-741), MANUFACTURE(60432-741), PACK(60432-741)
Revised: 08/2017   Morton Grove Pharmaceuticals, Inc.

How supplied

Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.

Storage

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Manufactured by: VINTAGE PHARMACEUTICALS, LLC, Huntsville, AL 35811. 8180671 R3/05. FDA Rev date: 2/24/2005

Acetic Acid Overview

Acetic acid is a prescription medication used to treat outer ear canal infections. This medication belongs to 2 groups of drugs -antibacterials and antifungals. It reduces pain and swelling in the ear by stopping bacteria and fungus from growing.

Acetic acid comes in the form of an ear drop. It is usually used 3 to 4 times daily. 

Common side effects include temporary burning or stinging in the ear canal.

What should i discuss with my health care provider before using acetic acid (acetasol)?

Do not use this medication if you are allergic to acetic acid, or if you have a hole in your ear drum (ruptured ear drum).

Before using acetic acid, tell your doctor if you are allergic to any drugs, or if you have severe ear pain, fever, or hearing problems. You may not be able to use acetic acid.

This medication is not expected to be harmful to an unborn baby. Before using any medication, tell your doctor if you are pregnant or breast-feeding a baby.

Do not use acetic acid ear drops in a child younger than 3 years old.

Side effects

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

Read the entire FDA prescribing information for Acetic Acid (Acetic Acid)

Read More »
(web3)