Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
hydrocortisone and acetic acid — Saptalis Pharmaceuticals, LLC
This page contains 11 source sections for HYDROCORTISONE AND ACETIC ACID OTIC, auricular (otic) route. Label set d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32, version 3.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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 and administration — label text
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
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
WARNINGS: Discontinue promptly if sensitization or irritation occurs.
Adverse reactions
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 .
Product description
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
Clinical pharmacology
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.
Precautions
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.
Children and adolescents
PEDIATRIC USE: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Supply and packaging
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).
Unclassified section
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
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.