Device Information

Rx Only – Prescription Medical Device

INGREDIENTS

Oxidized glycerol triesters (OGT), silicon dioxide, aspartame, and artificial flavoring.


ACTIONS

Aquoral™ is a lipid-based solution resembling human saliva designed to moisten and lubricate the oral cavity, including the oral mucosa of the mouth, tongue, and throat, by formation of a lipid film which limits loss of water and restores the viscoelasticity of the oral mucosa. Aquoral also provides protective action against further inflammation of the oral mucosa. Xerostomia (dry mouth) has harmful effects on the oral cavity and quality of life; consequently, management of dry mouth is primarily based on relief of symptoms.


HOW SUPPLIED

Carton of 4 individual Aquoral vials with 0.1 mL spray pump each containing 5.6 mL (0.189 fl. oz.), NHRIC 0178-0420-46.


INDICATIONS

Aquoral is intended to provide relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren’s syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. Aquoral relieves symptoms of dry mouth, such as difficulties in swallowing, speech, and changes in taste.


DIRECTIONS FOR USE

Shake gently. One dose (2 sprays) into the mouth 3 to 4 times a day. Spread product on to inflamed and/or dry areas of the mouth with the tongue. Pump may require priming for initial use.


CONTRAINDICATIONS

Aquoral is contraindicated for any patient with a known history of hypersensitivity to any of its ingredients.


PRECAUTIONS

Read package insert carefully before using this spray. Avoid contact with eyes. Flush eyes with water if accidental introduction into eyes should occur.


INTERACTIONS

There are no known interactions with medicinal or other products.

To report a serious adverse event or obtain product information call (800) 531-3333.

KEEP OUT OF THE REACH OF CHILDREN