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 Saptalis Pharmaceuticals, LLC at 1-833-727-8254 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 (0.015%). 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. Chemical Structure_Hydrocortisone

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 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.

20241223

2

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

NDA012770

Hydrocortisone and acetic acid

hydrocortisone and acetic acid otic

71656-064

HUMAN PRESCRIPTION DRUG

AURICULAR (OTIC)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 71656-064-10 Hydrocortisone and Acetic Acid Otic Solution, USP 1% / 2% For Otic Use Only Rx only 10 mL Label

STORAGE: Store at room temperature, 20°C to 25°C (68°F to 77°F). Keep container tightly closed. Rx only Distributed by: Saptalis Pharmaceuticals, LLC. Hauppauge, NY 11788 MADE IN USA May 2024-R3 PPM-0082

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 71656-064-10).

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.