Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
080145868
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Saptalis Pharmaceuticals, LLC
Saptalis Pharmaceuticals, LLC
081154447
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocortisone and acetic acid
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
DESCRIPTION SECTION
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.
CLINICAL PHARMACOLOGY SECTION
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 & USAGE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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.
CONTRAINDICATIONS SECTION
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 SECTION
WARNINGS: Discontinue promptly if sensitization or irritation occurs.
ADVERSE REACTIONS SECTION
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 orwww.fda.gov/medwatch.
HOW SUPPLIED SECTION
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).
SPL UNCLASSIFIED SECTION
STORAGE: Store at room temperature, 20° to 25°C (68° to 77°F). Keep container tightly closed.
Rx only
Distributed by:
Saptalis Pharmaceuticals, LLC
Hauppauge, NY 11788
MADE IN USA
January 2024-R2
PPM-0082