Official product label reference
Hydrocortisone and Acetic Acid — Sun Pharmaceutical Industries, Inc.
This page contains 12 source sections for HYDROCORTISONE AND ACETIC ACID, auricular (otic) route. Label set 6383c722-84e2-4719-a13d-19c54e3eefff, version 6.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
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 — label text
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.
Contraindications
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.
Warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
Adverse reactions
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Unclassified section
(Hydrocortisone and Acetic Acid Otic Solution, USP) Rx only
Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: May, 2015 PK-4785-1 61 0515-1
Product description
DESCRIPTION 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
Clinical pharmacology
CLINICAL PHARMACOLOGY Acetic acid is anti-bacterial 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.
Precautions
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.
Children and adolescents
Pediatric Use Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Supply and 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.
Table text from source:
| 10 mL bottle | NDC 51672-3007-1
Storage and handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
- Drugs@FDA application ANDA088759Application history where available; verify the specific product and indication.
Substances listed: HYDROCORTISONE, ACETIC ACID
Package NDC codes
51672-3007-1
Further research and background
These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.
Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.