hydrocortisone and acetic acid 20.75 mg/mL
hydrocortisone and acetic acid otic · SOLUTION · Saptalis Pharmaceuticals, LLC
hydrocortisone and acetic acid is a solution containing hydrocortisone and acetic acid otic at 20.75 mg/mL, taken auricular (otic). Manufactured by Saptalis Pharmaceuticals, LLC.
Key Facts
- Brand Name
- hydrocortisone and acetic acid
- Generic Name
- hydrocortisone and acetic acid otic
- NDC Code (Product)
71656-064- Manufacturer
- Saptalis Pharmaceuticals, LLC
- Strength
- 20.75 mg/mL
- Dosage Form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- NDA012770
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 02/23/2024
Recall History
No Recall HistoryFull Prescribing 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.
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.
Warnings
WARNINGS Discontinue promptly if sensitization or irritation occurs.
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.
Adverse Reactions
ADVERSE REACTIONS Stinging or burning may be noted occasionally; local irritation has occurred very rarely.
Frequently Asked Questions
What is hydrocortisone and acetic acid used for?
hydrocortisone and acetic acid contains hydrocortisone and acetic acid otic. It is a solution taken auricular (otic). Consult your doctor for specific uses.
Is hydrocortisone and acetic acid a controlled substance?
hydrocortisone and acetic acid is not classified as a controlled substance by the DEA.
What is the generic name for hydrocortisone and acetic acid?
The generic name for hydrocortisone and acetic acid is hydrocortisone and acetic acid otic. There are no other listed brand versions of hydrocortisone and acetic acid otic.
What is the NDC code for hydrocortisone and acetic acid 20.75 mg/mL?
The NDC (National Drug Code) for hydrocortisone and acetic acid 20.75 mg/mL is 71656-064, listed by Saptalis Pharmaceuticals, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)