December 1, 2015


How Supplied


Amlexanox oral paste, 5%, is indicated for the treatment of aphthous ulcers in people with normal immune systems.


The paste should be applied as soon as possible after noticing the symptoms of an aphthous ulcer and should be used four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a finger tip. With gentle pressure, dab the paste onto each ulcer in the mouth. Use of the medication should be continued until the ulcer heals. If significant healing or pain reduction has not occurred in 10 days, consult your dentist or physician.


Amlexanox oral paste, 5%, is supplied in 5 gram tubes (NDC10158-059-01). Amlexanox oral paste, 5%, should be stored at controlled room temperature, 15°-30°C (59°- 86°F).

Manufactured for: Oral Health Care Division, Block Drug Company, Inc., Jersey City, NJ 07302. By Reedco, Inc., Humacao, Puerto Rico 00791. June 2002.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/2/2009

How Supplied

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