HYDROCORTISONE 1% AND ACETIC ACID 2% OTIC SOLUTION, USP 1%/2% 10 ML
Generic: Hydrocortisone and Acetic Acid
HYDROCORTISONE 1% AND ACETIC ACID 2% OTIC SOLUTION, USP 1%/2% 10 ML
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Identification
Hydrocortisone and Acetic Acid
Hydrocortisone and Acetic Acid
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION
AURICULAR (OTIC)
ANDA088759
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACETIC ACID | 20.8 mg/mL |
| HYDROCORTISONE | 10.4 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
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.
Warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Dosage & Administration
DOSAGE AND ADMINISTRATION Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution 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 the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops 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.
Adverse Reactions
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.