"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 "...
DOSAGE AND ADMINISTRATION
The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
Dosage Forms And Strengths
CETRAXAL is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride quivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
Storage And Handling
CETRAXAL (ciprofloxacin otic solution) is a clear, colorless, sterile, preservative-free solution. CETRAXAL (ciprofloxacin otic solution) is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single use container. Each single use container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged in a foil overwrap pouch in a carton (NDC 66992-450-14).
Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.
CETRAXAL (ciprofloxacin otic solution) is: Distributed by: WraSer Pharmaceuticals, Ridgeland, MS 39157. Manufactured by: The Ritedose Corporation, Columbia, SC 29203 USA.
Last reviewed on RxList: 5/26/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cetraxal Information
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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