Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
12/17/2008
Trade Name:
Epiduo
Generic Name or Proper Name (*):
adapalene and benzoyl peroxide
Indications Studied:
Topical treatment of acne vulgaris in patients 12 years of age and older
Label Changes Summary:
Safety and effectiveness established in patients 12 years of age and older Safety and effectiveness in pediatric patients under the age of 12 have not been established New drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Galderma
NNPS:
FALSE'
Therapeutic Category:
Antiacne, topical
-
-