Hydrocortisone And Acetic Acid Solution
FDA Label NDC 0713-0849

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosette Pharmaceuticals, Inc. for the product Hydrocortisone And Acetic Acid (NDC 0713-0849). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, pediatric use, adverse reactions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description

→ Clinical Pharmacology

→ Indications And Usage

→ Contraindications

→ Warnings

→ Precautions

→ Pediatric Use

→ Adverse Reactions

→ Dosage And Administration

→ How Supplied

→ Storage

→ Package/label Principal Display Panel

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 ₃COOH, and C ₂₁H ₃₀O ₅, with a molecular weight of 60.05 and 362.46, respectively.
The structural formulas are:

Structure (Structure)

Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

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.

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.

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

Discontinue promptly if sensitization or irritation occurs.

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.

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.

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.

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).