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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:  02/16/2006
 
Trade Name:  Vusion Ointment
 
Generic Name or Proper Name (*):  miconazole
 
Indications Studied:  Adjunctive treatment of diaper dermatitis in children 4 weeks of age and older
 
Label Changes Summary:  Indicated for use in immunocompetent children Presence of candidal infection should be established by microscopic evaluation prior to initiating treatment Effectiveness based on three clinical studies in infants and toddlers Safety when used for more than 7 days is not known New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Barrier Therapeutics
 
NNPS:  FALSE'
 
Therapeutic Category:  Antifungal, topical
 
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