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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:  12/10/2003
Trade Name:  Ertaczo Cream
Generic Name or Proper Name (*):  sertaconazole
Indications Studied:  Treatment of interdigital tinea pedis (athlete's foot) in children 12 years of age and older
Label Changes Summary:  * Safety and effectiveness established in clinical trials involving adolescent patients * Studies in patients less than 12 years of age waived because there are too few children with the disease to study * New drug
Product Labeling:  Labeling  Opens a new window
Sponsor:  Mylan
Therapeutic Category:  Antifungal, topical