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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
3M Health
NNPS:
FALSE'
Therapeutic Category:
Antiseptic
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