INDICATIONS AND USAGE
For topical application to aid in the protection against dental caries.
DOSAGE AND ADMINISTRATION
Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. Point can toward applicator tray and slowly press nozzle to fill tray. Use one press per arch (foam will expand slightly to fill the tray). Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 1 minute or up to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for 30 minutes.
RECOMMENDED FREQUENCY
Not to exceed 4 treatments per year.
CONTRAINDICATIONS
Hypersensitivity to fluoride. Acidulated Phosphate Fluoride should not be used for patients with porcelain, composite restorations and sealants.
PRECAUTIONS
Do not swallow. Keep out of reach of children.
Safety and effectiveness below 3 years of age has not been established. There have been no long term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential. Laboratory studies have indicated that repeated use of Acidulated Phosphate Fluoride may dull porcelain, composite restorations, and sealants.
OVERDOSAGE
If treatment dose is swallowed (or less than 100 mg of Fluoride ion) administer milk, limewater, or calcium-type antacid. In case of larger doses swallowed (more than 100 mg of Fluoride ion) administer ipecac syrup emetic and immediately seek medical help. Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.
ADVERSE REACTIONS
Developing teeth of children under 6 years of age may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.
HOW SUPPLIED
2.73% sodium fluoride (1.23% fluoride ion) foam supplied in 4.4 fl.oz. aerosol container
Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]
Manufactured for:
DENTSPLY Professional
1301 Smile Way
York, PA 17404
1-800-989-8826
Made in U.S.A.
Danger: Extremely flammable aerosol.
Contains gas under pressure: may explode if heated.
May cause an allergic skin reaction. Causes serious eye damage.
SAFETY DATA SHEET is available on our website, www.dentsplysirona.com, or by contacting Customer Service at 1-800-989-8826.
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