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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:  04/09/2009
 
Trade Name:  Ulesfia Lotion, 5%
 
Generic Name or Proper Name (*):  benzyl alcohol
 
Indications Studied:  Treatment of head lice
 
Label Changes Summary:  * Safety and effectiveness established in pediatric patients 6 months and older * Safety in pediatric patients < 6 months has not been established. * Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption * Neonates are at risk of gasping syndrome due to benzyl alcohol * Adverse events similar to those observed in adults * Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sciele Pharma Inc
 
NNPS:  FALSE
 
Therapeutic Category:  Pediculocide, topical
 
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