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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:  05/18/2007
 
Trade Name:  Locoid Lotion 0.1%
 
Generic Name or Proper Name (*):  hydrocortisone butyrate
 
Indications Studied:  Treatment of mild to moderate atopic dermatitis in children 3 months of age and older
 
Label Changes Summary:  * Effectiveness established in one study of 284 patients from 3 months to 18 years of age * Information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area * Studies waived in children < 3 months of age * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ferndale Labs
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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