August 29, 2016
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"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 "...



Cetraxal Patient Information Including Side Effects

Brand Names: Cetraxal

Generic Name: ciprofloxacin otic (Pronunciation: SIP roe FLOX a sin OH tik)

What is ciprofloxacin otic (Cetraxal)?

Ciprofloxacin es an antibiotic that fights bacteria.

Ciprofloxacin otic (for the ears) is used to treat ear infections that affect the outer ear canal. This type of ear infection is sometimes called "swimmer's ear."

Ciprofloxacin otic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ciprofloxacin otic (Cetraxal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • the first sign of any skin rash, no matter how mild;
  • white patches in your mouth or throat; or
  • vaginal itching or discharge.

Less serious side effects may include:

  • headache; or
  • itching, pain, or mild irritation after using the ear drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Cetraxal (ciprofloxacin otic solution) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about ciprofloxacin otic (Cetraxal)?

You should not use this medication if you are allergic to ciprofloxacin (Cipro).

Avoid getting this medication in your mouth or eyes or on the skin. If it does get into any of these areas, rinse with water.

Stop using this medication and call your doctor at once if you have any skin rash (no matter how mild), white patches in your mouth or throat, or vaginal itching or discharge.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve after using ciprofloxacin otic, or if your symptoms get worse.

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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