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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:  02/07/2012
 
Trade Name:  Sklice
 
Generic Name or Proper Name (*):  ivermectin
 
Indications Studied:  Topical treatment of head lice infestations
 
Label Changes Summary:  "Safety and effectiveness in children 6 months and older have been established "Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity" Information on dosage and administration, adverse reactions, pharmacokinetics and clinical trials"New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sanofi-Topaz, Inc.
 
Therapeutic Category:  Pediculocide, topical
 
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