Why was auralgan removed from the market?

On July, 2, 2015 the FDA asked all manufacturers of antipyrine and benzocaine otic products (Auralgan and Aurodex brand names) to stop selling these products because they have not been proven to be safe and effective.

Is auralgan safe?

Auralgan is a well-known, old fashioned ear medicine used for decades by ENT doctors to ease pain in patients with ear infections. Its been around so long that it has a well established record of efficacy and safety as well as a generic form that is very inexpensive.

How long can you use auralgan?

Eardrops should be used within 1 or 2 months of opening, although the time period may vary from one product to another. Ask your pharmacist how long you can keep this medication. Generally, this medication is used only as needed. Important: Follow the instructions on the label.

Does auralgan remove ear wax?

Auralgan helps to remove wax in the ear canal, as well as provide pain relief for swimmer’s ear. It can also be used as an add-on product when you have otitis media.

Can you still buy auralgan?

Auralgan (benzocaine and antipyrine) otic drops are no longer manufactured. The FDA 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 pain, infection, and inflammation.

Is auralgan a prescription?

Auralgan is a prescription medicine used to treat the symptoms of inflammation of the middle ear (Acute Otitis Media) and to remove earwax (cerumen). Auralgan may be used alone or with other medications.

How often can you use auralgan?

Dosage for Auralgan Repeat every one to two hours per doctor’s instructions until pain and congestion are relieved.

Is auralgan an antibiotic?

Auralgan is a prescription medicine used to treat the symptoms of inflammation of the middle ear (Acute Otitis Media) and to remove earwax (cerumen). Auralgan may be used alone or with other medications. Auralgan belongs to a class of drugs called Otic Anesthetics.

Is auralgan safe for babies?

Auralgan belongs to a class of drugs called Otic Anesthetics. It is not known if Auralgan is safe and effective in children younger than 2 years of age.

How do you use Auralgan ear drops?

How to use Auralgan Drops. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal.

What are the possible side effects of Auralgan?

Auralgan. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects.

How is Auralgan used to treat otitis media?

To treat acute otitis media, the dose of Auralgan is to instill the solution into the wall of the ear canal until it is filled. Repeat every one to two hours per doctor’s instructions until pain and congestion are relieved. Auralgan may interact with other ear medications.

What are the side effects of earwax removal?

Common side effects include: 1 Stinging in the ear 2 Burning in the ear 3 Redness around the ear