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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
Sponsor:  Barrier Therapeutics
Therapeutic Category:  Antifungal, topical