Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
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
PREA(P):
P
Sponsor:
Sciele Pharma Inc
NNPS:
FALSE'
Therapeutic Category:
Pediculocide, topical
-
-