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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:  09/29/2006
 
Trade Name:  DuraPrep Surgical Solution
 
Generic Name or Proper Name (*):  iodine; isopropyl alcohol
 
Indications Studied:  Preoperative skin preparation for use in children 2 months of age and older OTC
 
Label Changes Summary:  * Effectiveness based on determination that permeability of skin in children > 2 months of age is essentially that of adult skin * Studies waived in children under 2 months of age for safety reasons and includes the following statement in the label: Do not use in children under 2 months of age due to excessive skin irritation and transient hypothyroidism. * New active ingredient
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  3M Health
 
NNPS:  FALSE
 
Therapeutic Category:  Antiseptic
 
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