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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Barrier Therapeutics
NNPS:
FALSE'
Therapeutic Category:
Antifungal, topical
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