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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:
12/12/2007
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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