First OTC Retinoid for Acne Approved

Differin Gel 0.1% (adapalene) approved to treat acne by FDA

(RxWiki News) The US Food and Drug Administration has approved the first over-the-counter (OTC) retinoid for the treatment of acne.

That medication is Differin Gel 0.1% (adapalene). This acne medication is approved for those 12 years of age and older and is to be applied once a day in a thin layer on the affected areas. 

Differin Gel 0.1% was initially approved in 1996 and could only be obtained with a prescription — until now. Not only is this medication the first retinoid to become OTC, but it is the first new OTC medication to be approved to treat acne since the 1980s. 

If you are pregnant, plan to become pregnant or are breastfeeding, this acne medication may not be safe to use. Ask your health care provider before using in these situations. Furthermore, do not use this product if you are allergic to Differin Gel or to any of its ingredients.

If you plan to use Differin Gel 0.1%, be sure to read the drug facts label before use.

This medication is for external use only. When applying, be sure to avoid getting the gel on your lips or in your mouth and eyes.

Do not apply Differin Gel on damaged skin. This may include cuts, scrapes or sunburns. Furthermore, when using this acne treatment, take the necessary precautions to avoid becoming sunburned. 

In the first few weeks of starting Differin Gel, you may notice skin irritation. Symptoms may include itching, dryness, redness and burning. If irritation becomes severe, contact your  health care provider. 

If you do not notice an improvement in your acne after using this medication for three months, speak with your health care provider. 

Speak to your health care provider about the best acne treatment for you. 

Differin Gel is distributed by Galderma Laboratories, L.P.

Review Date: 
July 8, 2016