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:
01/18/2011
Trade Name:
Natroba
Generic Name or Proper Name (*):
spinosad
Indications Studied:
Treatment of head lice infestation in patients 4 years of age and older
Label Changes Summary:
Safety and effectiveness have been established in pediatric patients 4 years of age and older Safety in pediatric patients < 4 years has not been established. Not recommended in pediatric patients< 6 months because of the potential for increased systemic absorptionNatroba contains benzyl alcohol which has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicityInformation on clinical trials, adverse reactionsNew drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
ParaPRO
NNPS:
FALSE'
Therapeutic Category:
Pediculocide, topical
-
-