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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:  11/11/2016
 
Trade Name:  Naftin
 
Generic Name or Proper Name (*):  naftifine hydrochloride
 
Indications Studied:  Tinea corporis in pediatric patients 2 years and older
 
Label Changes Summary:  *Expanded the indication down to pediatric patients 2 years and older; previously approved in pediatric patients 12 years and older. *Safety and effectiveness in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, pharmacokinetic parameters, and clinical trials. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merz Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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