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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
 
PREA(P):  P
 
Sponsor:  Mylan
 
NNPS:  FALSE'
 
Therapeutic Category:  Antifungal, topical
 
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