• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
Pediatric Labeling Date:  09/30/2003
Trade Name:  Floxin Otic Solution
Generic Name or Proper Name (*):  ofloxacin
Indications Studied:  Treatment of otitis externa (outer ear infection) in children 6 months of age and older
Label Changes Summary:  * Dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients * New dosing regimen
Product Labeling:  Labeling  Opens a new window
Sponsor:  Daiichi
Therapeutic Category:  Antibiotic