• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-