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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
Sponsor:  Westwood-Squibb
Pediatric Exclusivity Granted Date:  10/01/1999
Therapeutic Category:  Moisturizer