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Pediatric and Off-Label Indications for Azelaic Acid Gel

Is It Safe for Children?

Azelaic acid gel is not approved for use in children or adolescents, as it has not been adequately studied in people under the age of 18. Talk with your child's healthcare provider about the benefits and risks of using azelaic acid gel in children. The cream form of azelaic acid (Azelex®) is approved for treating acne in children as young as 12 years old.
 

Are There Off-Label Reasons to Use Azelaic Acid Gel?

On occasion, your healthcare provider may recommend this medication for something other than rosacea treatment. This is known as an "off-label" use.
 
Sometimes, azelaic acid gel is used off-label for the treatment of dark spots caused by pregnancy or other hormonal changes (medically known as melasma). Applying azelaic acid gel to treat acne would also be an off-label use. There is actually a cream version of azelaic acid (Azelex) approved for acne treatment.

Azelaic Acid Gel Drug Information

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