"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
(fluocinolone acetonide) Oil Ear Drops
For Otic Use Only
Not for Ophthalmic Use
Fluocinolone acetonide in DermOtic® Oil (fluocinolone acetonide oil ear drops) has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of DermOtic® Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances.
What are the precautions when taking fluocinolone acetonide oil ear drops (DermOtic Oil)?
Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve.
During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional DermOtic Oil Information
DermOtic Oil - User Reviews
DermOtic Oil User Reviews
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