• 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:  11/09/2005
Trade Name:  Fluocinolone Acetonide Oil
Generic Name or Proper Name (*):  fluocinolone
Indications Studied:  Chronic eczematous external otitis (outer ear) in children 2 years of age and older
Label Changes Summary:  * Effectiveness established in studies of patients 2 years of age and older * New indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  Hill Dermaceuticals
Therapeutic Category:  Anti-inflammatory, topical