HYDROCORTISONE AND ACETIC ACID solution

hydrocortisone and acetic acid by

Drug Labeling and Warnings

hydrocortisone and acetic acid by is a Prescription medication manufactured, distributed, or labeled by Akorn Operating Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Pregnancy

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

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 901:01 5/09

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

AKORN

NDC: 50383-901-10

Hydrocortisone and Acetic Acid Otic Solution, USP

10 mL

Rx only

INGREDIENTS AND APPEARANCE

HYDROCORTISONE AND ACETIC ACID 
hydrocortisone and acetic acid solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	20.75 mg  in 1 mL
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10.375 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
SODIUM ACETATE (UNII: 4550K0SC9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50383-901-10	1 in 1 CARTON	06/04/2009
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012770	06/04/2009

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

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(50383-901)