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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Barrier Therapeutics
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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