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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:  12/12/2007
 
Trade Name:  Derma-Smoothe/FS Topical Oil
 
Generic Name or Proper Name (*):  fluocinolone
 
Indications Studied:  Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks
 
Label Changes Summary:  * Extended age range down to 3 months * Effectiveness and safety are not established in children less than 3 months old * Safety was evaluated in two pediatric clinical studies (including facial use) * Pediatric dosing and administration information provided * Studies waived in children under 3 months of age due to safety concerns of adrenal suppression * New indication
 
PREA(P):  P
 
Sponsor:  Hill
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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