Hydrocortisone and acetic acid

ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

DESCRIPTION Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.0025%). The empirical formulas for acetic acid and hydrocortisone are CH 3 COOH, and C 21 H 30 O 5 , 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. Structure

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.

WARNINGS Discontinue promptly if sensitization or irritation occurs.

CLINICAL PHARMACOLOGY Acetic acid is antibacterial 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.

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hydrocortisone and acetic acid hydrocortisone and acetic acid ANHYDROUS CITRIC ACID BENZETHONIUM CHLORIDE PROPYLENE GLYCOL PROPYLENE GLYCOL DIACETATE SODIUM ACETATE ACETIC ACID ACETIC ACID HYDROCORTISONE HYDROCORTISONE

ANDA040609

Hydrocortisone and acetic acid

hydrocortisone and acetic acid

0713-0849

HUMAN PRESCRIPTION DRUG

AURICULAR (OTIC)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0713- 0849 -09 Rx only Hydrocortisone and Acetic Acid Otic Solution, USP 10 mL Cosette Pharmaceuticals, Inc. NDC 0713- 0849 -09 Rx only Hydrocortisone and Acetic Acid Otic Solution, USP 10 mL Cosette Pharmaceuticals, Inc. Carton Bottle

STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Rx only Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 12/2023 8-0849CPLNC1 VC7758

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

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 0713-0849-09).

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.