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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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