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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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