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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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
 
PREA(P):  P
 
Sponsor:  Hill Dermaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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