Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle. 10 mL bottle NDC 51672-3007-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.; PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton 10 mL NDC 51672-3007-1 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP FOR OTIC USE ONLY. Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
- HOW SUPPLIED Hydrocortisone 1% and acetic acid 2% otic solution is available in 10 mL plastic, controlled dropper tip bottle. 10 mL bottle NDC 51672-3007-1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.
- PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton 10 mL NDC 51672-3007-1 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP FOR OTIC USE ONLY. Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
Overview
Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%). Acetic acid has a molecular formula of CH 3 COOH with molecular weight of 60.05. The structural formula is: Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C 21 H 30 O 5 with molecular weight 362.46. The structural formula is: Hydrocortisone and acetic acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal. Chemical Structure Chemical Structure
Indications & 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 & 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.
Warnings & Precautions
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Contraindications
Hypersensitivity to hydrocortisone and acetic acid otic solution 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.
Adverse Reactions
Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.
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