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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Mylan
NNPS:
FALSE'
Therapeutic Category:
Antifungal, topical
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