Canker sores are shallow, painful sores in your mouth that are usually red and may sometimes have a white coating over them. Canker sores often appear on the inside of your lips and cheeks, the base of your gums or under your tongue. Canker sores are different from fever blisters, which are usually on the outside of your lips or the corners of your mouth. Anyone can get canker sores, however, women, teens and people in their 20s suffer from canker sores most frequently. Canker sores are not contagious. Doctors do not know what causes canker sores, but they may be triggered by stress, poor nutrition, food allergies, menstrual periods and trauma.

Aphthasol is the first FDA-approved (and only available) prescription drug specifically indicated for the treatment of Recurrent Aphthous Ulcers (RAUs) more commonly known as Canker Sores. Aphthasol is a viscous, topical paste that is placed directly over the canker sore several times per day to accelerate the healing process.

Amlexanox, 5%.

Aphthasol is a beige-colored, adhesive oral paste consisting of benzyl alcohol, gelatin, glyceryl monostearate, mineral oil, pectin, petrolatum and sodium carboxymethylcellulose. Each gram of beige-colored oral paste contains 50mg of Amlexanox (an odorless, white to yellowish-white crystalline powder).

Aphthasol is indicated for the treatment of aphthous ulcers in people with normal immune systems (Aphthasol is indicated for individuals 18 years and older).

Aphthasol (amlexanox oral paste), 5%, is contraindicated in patients with known hypersensitivity to amlexanox or other ingredients in the formulation.

Adverse reactions reported by 1-2% of the patients transient pain, stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea and diarrhea.

Aphthasol (amlexanox oral paste), 5%, is supplied in a 5 gram tube (NDC67404-100-05). Aphthasol (amlexanox oral paste), 5%, should be stored at controlled room temperature, 15° - 30°C (59° - 86°F).