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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
Therapeutic Category:  Anti-inflammatory, topical