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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:  08/25/2000
 
Trade Name:  Lac-Hydrin
 
Generic Name or Proper Name (*):  ammonium lactate
 
Indications Studied:  Xerosis, ichthyosis
 
Label Changes Summary:  * Safety and effectiveness established in patients 2  11 years of age; previously approved ³12 years of age
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Westwood-Squibb
 
Pediatric Exclusivity Granted Date:  10/01/1999
 
NNPS:  FALSE
 
Therapeutic Category:  Moisturizer
 
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