FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Discontinue promptly if sensitization or irritation occurs.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.
History
There is currently no drug history available for this drug.
Other Information
Hydrocortisone and Acetic Acid Otic Solution USP, is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid (0.2%). The molecular formulas for acetic acid and hydrocortisone are C2H4O2 and C21H30O5, with molecular weights of 60.05 and 362.46, respectively. The structural formulas are:
Chemically, hydrocortisone is: Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-(11ß)-.
This product is available as a nonaqueous otic solution buffered at pH 2 to 4 for use in the external ear canal.
Sources
Acetasol Hc Manufacturers
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Actavis Mid Atlantic Llc
Acetasol Hc | Actavis Mid Atlantic Llc
Carefully remove all cerumen and debris to allow 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 solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of solution 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.
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