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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:
07/28/2006
Trade Name:
Xolegel Gel
Generic Name or Proper Name (*):
ketoconazole
Indications Studied:
Treatment of seborrheic dermatitis in children 12 years of age and older
Label Changes Summary:
Effectiveness established from studies in patients 12 years of age and older Safety and effectiveness in pediatric patients below 12 years of age have not been establishedstudies waived in children 0-12 years of age New dosage form
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Barrier Therapeutics
NNPS:
FALSE'
Therapeutic Category:
Antifungal, topical
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