Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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:  10/10/2014
 
Trade Name:  Naftin
 
Generic Name or Proper Name (*):  naftifine hydrochloride
 
Indications Studied:  Interdigital tinea pedis
 
Label Changes Summary:  Use in 12 – 18 years is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial in 22 adolescents 12 years and older exposed to Naftin Gel at a dose of approximately 4 g/day Safety and effectiveness in pediatric patients less than12 years have not been established Adverse reactions were similar to those observed in adults Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merz Pharmaceuticals
 
NNPS:  FALSE'
 
Therapeutic Category:  Antifungal, topical
 
-
-