ORAL-B MINUTE-FOAM BUBBLE GUM
(acidulated phosphate fluoride)
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||unapproved drug other|
Topical Fluoride Foaming Solution
(Acidulated Phosphate Fluoride Containing 1.23 % w/w Fluoride Ion)
FOR PROFESSIONAL USE ONLY
Active Ingredient:Acidulated Phosphate Fluoride (Sodium Fluoride and Hydrofluoric Acid) 1.23 % w/w fluoride ion.
Do not use in patients with dysphagia.
Accidental ingestion of the usual treatment dose (approx 12.4 mg of fluoride) is not harmful. In the event more than the treatment dose is swallowed, administer calcium (e.g. milk) and get medical or contact a Poison control Center right away. One bottle of Minute Foam contained 1.95 grams of fluoride ion which could be lethal for children adults.
Keep out of the reach of infants and children under 12 years.
Pediatric patients under age 12 should be supervised during use of this product.
Avoid spraying towards open flame.
Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures over 120 F (49 C).
PRECAUTIONS: FOR PROFESSIONAL USE ONLY
Laboratory studies have indicated that repeated use of Acidulated Phosphate Fluoride products may dull porcelain and composite restorations.
Safety and effectiveness below age 6 have not been established. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential.
No evidence of carcinogenicity was observed in female and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocal evidence of carcinogenicity was reported in male rats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed in female rates (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risks in humans (7).
Fluoride ion is not mutagenic in standard bacterial systems but has been associated with genetic aberrations in cultured human cells at doses much higher than expected for human exposure (6,8). Some in vivo studies report chromosomal aberrations in rodents while other studies using similar protocols report negative results (7).
Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse reproductive effects of fluoride have been reported in animal studies, but at high concentrations sufficient to produce other manifestations of toxicity (9).
A standard treatment dose of Minute-Foam contains approximately 12.4 mg fluoride. One 165 g (5.8oz) bottle contains approximately 1.95 g of fluoride.
This initial time you dispense from a new bottle, gently lift upward on the nozzle to break the protective seal (thin plastic located adjacent to trigger). If this seal is broken do not use the product.
Shake bottle vigorously for 3-4 seconds prior to dispensing.
Invert bottle 180 degree with nozzle tip pointed downward into tray.
Place nozzle tip close to the tray floor and at one end of the tray arch. Moving from one end of the tray to the other in one fluid motion, slowly press down on the trigger.
Dispense foam into applicator tray. (Note: foam will expand slightly to fill the tray.)
Immediately place trays in mouth. (Do not fill trays with foam too far in advance of treatment as the foam will collapse and not be as effective.)
Have patient bite down on the trays lightly but firmly for 4 minutes.
Remove trays and have patient expectorate excess.
Instruct patient not to eat, drink, or rinse for at least 30 minutes.
For optimal tooth coverage, use a fluoride applicator tray which is deep enough to reach the entire vertical height of all teeth (even the molars)
HOW SUPPLIED: Minute-Foam is available in a 165 g (5.8 oz) plastic aerosol container in six different flavors; NDC 0041-0340-06 Banana Splitz, NDC 0041-03141-06 Mellow Mint, NDC 0041-0342-06 Orang-a-Tangy, NDC 0041-0345-06 Bubblegum, NDC 0041-0346-06 Strawberry, NDC 0041-0347-06 Grape Punch.
(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, H et al.:J. Dent, 33, 469-473 (2005) (3.) National Toxicology Program: NTP TR 393, NIH Publication 91-2842, (1990) (4.) Bucker, J.R et al.L Int. J. Cancer 48, 1118-1126 (1990) (6.) Martin, G.R. et al.: Mutat. Res. 66, 159-167 (1979) (7.) Agency for toxic Substances and Disease Registry: Toxicological Profile for Fluorides (2003) (8.) Aardema, M.J. et al.: Mutat. Res. 331 (1), 171-172 (9.) National Research Council: Fluoride in Drinking Water (2006) (10.) Heindel, J.J. et al.: Fundam Appl Toxicol, 30, 162-177 (1996) (11.) Institute of Medicine, Food and Nutrition Board: Dietary Reference Intakes (1997) (12.) Collins, T.F et al.: Food Chem. Toxicol. 33 (11), 951-960 (13.) Collins, T.F. et al.: Food Chem Toxicol. 39 (8), 867-876
|ORAL-B MINUTE-FOAM BUBBLE GUM
acidulated phosphate fluoride aerosol
|Labeler - Oral-B Laboratories (183102243)|