HYDROCORTISONE AND ACETIC ACID- hydrocortisone and acetic acid solution
Actavis Pharma, Inc.
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 C2 H4 O2 and C21 H30 O5 , 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.
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.
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
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.
Discontinue promptly if sensitization or irritation occurs.
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.
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
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.
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.
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised — March 2016
| HYDROCORTISONE AND ACETIC ACID |
hydrocortisone and acetic acid solution
|Labeler — Actavis Pharma, Inc. (119723554)|
|G&W NC Laboratories, LLC||079419931||ANALYSIS (45963-412), LABEL (45963-412), MANUFACTURE (45963-412), PACK (45963-412)|
Revised: 03/2016 Actavis Pharma, Inc.
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