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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:  06/29/2006
 
Trade Name:  Lidocaine and Tetracaine Cream
 
Generic Name or Proper Name (*):  lidocaine; tetracaine
 
Indications Studied:  Topical local analgesia for superficial dermatological procedures
 
Label Changes Summary:  * Studies failed to show effectiveness over placebo in reducing the pain associated with venipuncture in pediatric patients 5-17 years of age * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ZARS
 
NNPS:  FALSE
 
Therapeutic Category:  Anesthetic, topical
 
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