Name: Acetic Acid
IrrigationSolution 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.
Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.
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.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
KEEP CONTAINER TIGHTLY CLOSED
Product No.: 8741
Wockhardt USA, LLC
Parsippany, NJ 07054
Morton Grove Pharmaceuticals, Inc
Morton Grove, IL 60053
Principal display panel
DO NOT USE IF BAND
PRINTED "SEALED FOR YOUR
PROTECTION" AROUND CAP
IS BROKEN OR MISSING.
|Acetic Acid |
Acetic Acid solution
|Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)|
|Registrant - Morton Grove Pharmaceuticals, Inc. (801897505)|
|Morton Grove Pharmaceuticals, Inc.||801897505||ANALYSIS(60432-741), LABEL(60432-741), MANUFACTURE(60432-741), PACK(60432-741)|
Acetic Acid Otic Solution, USP, containing 2% acetic acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.
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.
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 »