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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:  03/29/2013
 
Trade Name:  Salonpas Pain Relief
 
Generic Name or Proper Name (*):  methyl salicylate 10% and l-menthol 3%
 
Indications Studied:  Temporary relief of mild to moderate aches and pains of muscles and joints associated with arthritis, simple backache, strains, bruises and sprains
 
Label Changes Summary:  Children under 18 years of age: do not use; this product has not been shown to work in children Postmarketing study
 
PREA(P):  P
 
Sponsor:  Hisamitsu Pharmaceutical Co., Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Analgesic, topical
 
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