HYDROCORTISONE AND ACETIC ACID - acetic acid and hydrocortisone solution 
Hi-Tech Pharmacal Co., Inc.

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Hydrocortisone and Acetic Acid Otic Solution, USP

DESCRIPTION

Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%) and citric acid (0.05%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:

Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

CLINICAL PHARMACOLOGY

Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, 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 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 and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and Acetic Acid 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 Hydrocortisone and Acetic Acid every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Hydrocortisone and Acetic Acid 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, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC 50383-901-10).

STORAGE

Store at room temperature, 20°- 25°C (68°-77°F). Keep container tightly closed.

Rx only

PRINCIPAL DISPLAY PANEL

Label

Carton

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev 901:01 5/09

MG# 27762

HYDROCORTISONE AND ACETIC ACID  hydrocortisone and acetic acid   solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50383-901 Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETIC ACID (ACETIC ACID) ACETIC ACID 20.75 mg  in 1 mL HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10.375 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   BENZETHONIUM CHLORIDE   PROPYLENE GLYCOL   PROPYLENE GLYCOL DIACETATE   SODIUM ACETATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50383-901-10 10 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA012770	06/04/2009

Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)

Revised: 10/2009Hi-Tech Pharmacal Co., Inc.