Hydrocortisone and Acetic Acid

ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

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.

DESCRIPTION Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%). Acetic acid has a molecular formula of CH 3 COOH with molecular weight of 60.05. The structural formula is: 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 C 21 H 30 O 5 with molecular weight 362.46. The structural formula is: 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. Chemical Structure Chemical Structure

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.

WARNINGS Discontinue promptly if sensitization or irritation occurs.

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.

20241219

4

Hydrocortisone and Acetic Acid Hydrocortisone and Acetic Acid PROPYLENE GLYCOL PROPYLENE GLYCOL DIACETATE BENZETHONIUM CHLORIDE SODIUM ACETATE ANHYDROUS CITRIC ACID HYDROCORTISONE HYDROCORTISONE ACETIC ACID ACETIC ACID

ANDA088759

Hydrocortisone and Acetic Acid

Hydrocortisone and Acetic Acid

51672-3007

HUMAN PRESCRIPTION DRUG

AURICULAR (OTIC)

PRINCIPAL DISPLAY PANEL - 10 mL Bottle 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 Bottle Carton

(Hydrocortisone and Acetic Acid Otic Solution, USP) Rx only

Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

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.