hydrocortisone and acetic acid otic

FDA Drug Profile — hydrocortisone and acetic acid

Drug Details

Generic Name
hydrocortisone and acetic acid otic
Brand Names
hydrocortisone and acetic acid
Application Number
NDA012770
Sponsor
Saptalis Pharmaceuticals, LLC
NDC Codes
1
Dosage Forms
SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients
ACETIC ACID, HYDROCORTISONE

Indications and 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.

Warnings

WARNINGS: Discontinue promptly if sensitization or irritation occurs.