Finished product reference
Hydrocortisone / Acetic Acid
Solution, Drops Auricular ( · Otic · ) 1 %/2 % 10 mL
- List code
- 11281
- Pharmacologic class
- Corticosteroid
What it is and how it works
Mechanism class: Corticosteroid Hormone Receptor Agonists
Indications
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 (summary)
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.
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 and precautions
WARNINGS: Discontinue promptly if sensitization or irritation occurs.
Storage and supply
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).
Source: Hydrocortisone And Acetic Acid Otic (Hydrocortisone And Acetic Acid) — US FDA prescribing information, 2025-04-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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