HYDROCORTISONE AND ACETIC ACID- hydrocortisone and acetic acid solution 
Taro Pharmaceuticals U.S.A., Inc.

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Hydrocortisone 1%
and Acetic Acid 2%
Otic Solution

(Hydrocortisone and Acetic Acid Otic Solution, USP)

Rx only

DESCRIPTION

Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing propylene glycol diacetate (3%) and benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.2%).

Acetic acid has a molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:

Chemical Structure

Acetic Acid

Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:

Chemical Structure

Hydrocortisone

Hydrocortisone and acetic acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.

CLINICAL PHARMACOLOGY

Acetic acid is anti-bacterial and antifungal; hydrocortisone is anti-inflammatory, antiallergic and antipruritic; 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 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 hydrocortisone and acetic acid otic solution or 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.

DOSAGE AND ADMINISTRATION

Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic 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 the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops 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 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle.

 
10 mL bottle NDC 51672-3007-1

Store at 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Mfd. by: Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Issued: June 2004

PK-4785-0 149

PRINCIPAL DISPLAY PANEL - 10 mL Carton

10 mL

NDC 51672-3007-1

Hydrocortisone 1%
and Acetic Acid 2%
Otic Solution USP

FOR OTIC USE ONLY.

Keep this and all
medications out of the
reach of children.

Rx only

TARO

PRINCIPAL DISPLAY PANEL - 10 mL Carton
HYDROCORTISONE AND ACETIC ACID 
hydrocortisone and acetic acid solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-3007
Route of Administration AURICULAR (OTIC) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10.4 mg  in 1 mL
Acetic Acid (UNII: Q40Q9N063P) (Acetic Acid - UNII:Q40Q9N063P) Acetic Acid 20.8 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
propylene glycol (UNII: 6DC9Q167V3)  
propylene glycol diacetate (UNII: 5Z492UNF9O)  
benzethonium chloride (UNII: PH41D05744)  
sodium acetate (UNII: 4550K0SC9B)  
anhydrous citric acid (UNII: XF417D3PSL)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51672-3007-1 1 in 1 CARTON
1 10 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088759 04/28/2005
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE

Revised: 8/2011
Document Id: 179ee80a-20b0-436b-8689-570f31d7e8d6
Set id: 6383c722-84e2-4719-a13d-19c54e3eefff
Version: 1
Effective Time: 20110829
 
Taro Pharmaceuticals U.S.A., Inc.