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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:  10/10/2001
 
Trade Name:  Derma-Smoothe/FS Topical Oil
 
Generic Name or Proper Name (*):  fluocinolone
 
Indications Studied:  Atopic dermatitis
 
Label Changes Summary:  Approved down to 2 years of age
 
Product Labeling:  Labeling  Opens a new window
 
Pediatric Rule (R):  R
 
Sponsor:  Hill
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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