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Acetic Acid Prescribing Information

Package insert / product label
Dosage form: otic solution
Drug class: Otic anti-infectives

Medically reviewed by Drugs.com. Last updated on Jun 7, 2024.

Rx only

Acetic Acid Description

Acetic acid otic solution, USP is a solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. The molecular formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:

Chemical Structure

Acetic acid otic solution, USP is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

Acetic Acid - 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 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 otic solution 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/Side Effects

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

To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1­800-FDA-1088 or www.fda.gov/medwatch.

Acetic Acid Dosage and Administration

Carefully remove all cerumen and debris to allow acetic acid otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic solution 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 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal.

How is Acetic Acid supplied

Acetic acid otic solution, USP, containing 2% acetic acid, is available in 15 mL measured‑drop, safety-tip plastic bottles.

NDC 52817-816-15 15 mL Bottle

Storage and Handling

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

Manufactured by:

Saptalis Pharmaceuticals, LLC

Hauppauge, NY 11788

Distributed by:

TruPharma, LLC

Tampa, FL 33609

Rev. 03/20-R1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 52817-816-15

Acetic Acid Otic Solution
USP, 2%

Rx only

15 mL

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 52817-816-15
Acetic Acid Otic Solution
USP, 2%

Rx only

15 mL

Carton

ACETIC ACID
acetic acid solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52817-816
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID20.65 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
SODIUM ACETATE (UNII: 4550K0SC9B)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52817-816-151 in 1 CARTON06/05/2020
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04060706/05/2020
Labeler - TruPharma, LLC (078533947)
Registrant - Saptalis Pharmaceuticals, LLC (080145868)
Establishment
NameAddressID/FEIBusiness Operations
Saptalis Pharmaceuticals, LLC081154447MANUFACTURE(52817-816)