Hydrocortisone and Acetic Acid
Package insert / prescribing information
Dosage form: otic solution
Drug class: Otic steroids with anti-infectives
Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.
On This Page
Rx Only
Hydrocortisone and Acetic Acid Description
Hydrocortisone and Acetic Acid Otic Solution USP, is a solution containing hydrocortisone USP, (1%) and acetic acid USP, (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid (0.2%). The molecular formulas for acetic acid, USP and hydrocortisone, USP are C2H4O2 and C21H30O5, with molecular weights of 60.05 and 362.46, respectively. The structural formulas are:

Chemically, hydrocortisone, USP is: Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-(11ß)-.

Acetic Acid, USP
This product is available as a nonaqueous otic solution buffered at pH 2 to 4 for use in the external ear canal.
Hydrocortisone and Acetic Acid - Clinical Pharmacology
Acetic acid is anti-bacterial and anti-fungal; hydrocortisone is anti-inflammatory, anti-allergic and anti-pruritic; 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 Hydrocortisone and Acetic Acid
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
Contraindications
Hypersensitivity to any of the ingredients, herpes simplex, vaccinia and varicella. 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
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Hydrocortisone and Acetic Acid Dosage and Administration
Carefully remove all cerumen and debris to allow solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the 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 to 5 drops of solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
HOW SUPPLIED
Hydrocortisone and Acetic Acid Otic Solution USP, 1%/2% is available in a 10 mL measured-drop, safety-tip plastic bottle (NDC 45963-412-61).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Keep container tightly closed.
Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised - March 2016
365I602-1180 GW7077
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid solution |
|||||||||||||
|
|||||||||||||
|
|||||||||||||
|
|||||||||||||
|
|||||||||||||
|
Labeler - Actavis Pharma, Inc. (119723554) |
Establishment | |||
Name | Address | ID/FEI | Operations |
G&W NC Laboratories, LLC | 079419931 | ANALYSIS(45963-412), LABEL(45963-412), MANUFACTURE(45963-412), PACK(45963-412) |
More about acetic acid / hydrocortisone otic
- Pricing & coupons
- Reviews (6)
- Side effects
- Drug class: otic steroids with anti-infectives
- En español
Patient resources
- Drug Information
- Hydrocortisone and acetic acid Otic (Advanced Reading)
- Acetic Acid, Propylene Glycol Diacetate, and Hydrocortisone