PEDIATRIC USE SECTION.
PediatricUse: The use of fluoride solutions, gels, and foamscontaining up to 1.23 fluoride ion as caries preventives in pediatricpatients aged to 16 years is supported by clinical studies in students aged 6to 12 years (1,2). Safety and effectiveness in pediatric patients below the ageof years has not been established. Please refer to CONTRAINDICATIONS andWARNINGS sections.
OVERDOSAGE: Accidental ingestionof large amounts of fluoride can result in acute irritation of the mouth andgastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastriccramping and abdominal pain. If large amounts of fluoride equal to or greaterthan 5mg fluoride/kg body weight (or 2.3 mg fluoride/lb body weight) areingested, give calcium (e.g. milk, 5% calcium gluconate or calcium lactatesolution) orally to relieve gastrointestinal symptoms and admit immediately toa hospital facility. standard treatment dose of Minute-Foamcontains approximately 12.4 mg fluoride. One 165 (5.8oz) bottle containsapproximately 1.95 of fluoride.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Minute Foam Label Image of Label.
HOW SUPPLIED SECTION.
HOWSUPPLIED: Minute-Foam is available in 165 (5.8 oz) plasticaerosol container in six different flavors; NDC 0041-0340-06 Banana Splitz, NDC0041-03141-06 Mellow Mint, NDC 0041-0342-06 Orang-a-Tangy, NDC 0041-0345-06Bubblegum, NDC 0041-0346-06 Strawberry, NDC 0041-0347-06 Grape Punch.
INACTIVE INGREDIENT SECTION.
InactiveIngredients:Purifiedwater, poloxamer 407, isobutane, poloxamer 234, phosphoric acid, sodiumsaccharin, flavor.
INDICATIONS & USAGE SECTION.
INDICATIONAND USE:A topically-appliedfoaming solution to aid in the prevention of dental caries.
NURSING MOTHERS SECTION.
NursingMothers: Due to the relative insensitivity of human milkfluoride levels to changes in maternal fluoride intake, and due to the lowconcentrations of fluoride in human milk, fluoride supplementation duringlactation would not be expected to significantly affect fluoride intake by thenursing infant (11). However, caution should be exercised when fluoride isadministered to nursing women.
ADVERSE REACTIONS SECTION.
ADVERSEREACTIONS: Developing teeth of children under age maybecome permanently discolored if excessive amounts are repeatedly swallowed.The following adverse reactions are possible in individuals hypersensitive tofluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache andweakness.
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.
Carcinogenesis,Mutagenesis, Impairment of Fertility:No evidence of carcinogenicity was observed in female and male mice at dosesranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocalevidence of carcinogenicity was reported in male rats at doses ranging from 2.5to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed infemale rates (3,4). In another study, no carcinogenicity was observed in ratstreated with fluoride up to25 mg/kg of body weight (5). Overall,epidemiological studies do not show an association between fluoridated drinkingwater and increased cancer risks in humans (7). Fluoride ion is not mutagenic in standard bacterial systems but has beenassociated with genetic aberrations in cultured human cells at doses muchhigher than expected for human exposure (6,8). Some in vivo studies reportchromosomal aberrations in rodents while other studies using similar protocolsreport negative results (7). Potential adverse reproductive effects of fluoride exposure in humans have notbeen adequately evaluated. Adverse reproductive effects of fluoride have beenreported in animal studies, but at high concentrations sufficient to produceother manifestations of toxicity (9).
CLINICAL PHARMACOLOGY SECTION.
CLINICALPHARMACOLOGY: Acidulated Phosphate Fluoride inhibits cariesformation by reducing enamel solubility and enhancing remineralization.
CONTRAINDICATIONS: Do not use in patients with hypersensitivityto fluoride. Do not use in patients withdysphagia.
DESCRIPTION:Oral-BMinute Foam is flavored aqueous foaming solution of acidulated phosphatesodium fluoride with pH of 3.5 and fluoride ion concentration of 1.23% w/w.
DOSAGE & ADMINISTRATION SECTION.
DOSAGEAND ADMINISTRATION: Adults and Children years and over: Use foam2 times year. This initial time you dispense from newbottle, gently lift upward on the nozzle to break the protective seal (thinplastic located adjacent to trigger). If this seal is broken do not use theproduct. 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 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 fluoride applicator tray which is deep enough to reach the entire vertical height of all teeth (even the molars).
GERIATRIC USE SECTION.
GeriatricUse: No overall differences in safety or effectivenesshave been observed between geriatric and younger patients. This drug is knownto be substantially excreted by the kidney, therefore the risk of toxicreactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function, careshould be taken in dose selection, and it may be useful to monitor renalfunction.
Pregnancy:TeratogenicEffects: Pregnancy Category B. Fluoride readily crosses theplacenta (7,9). Animal studies (rats and rabbits) have shown that fluoride isnot teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of bodyweight did not affect maternal body weight, litter size or fetal weight and didnot increase frequency of skeletal or visceral malformations (10). There are noadequate and well-controlled studies in pregnant women. Several epidemiologicalstudies show no increase in birth defects in areas with fluoridated watercompared to areas with low fluoridated water (7). However, caution should be exercisedwhen fluoride is administered to pregnant women.
REFERENCES:(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, 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.
SPL PATIENT PACKAGE INSERT SECTION.
MINUTE-FOAMTopical FluorideFoaming Solution(Acidulated Phosphate Fluoride Containing 1.23 w/w Fluoride Ion) FOR PROFESSIONAL USEONLY ActiveIngredient:Acidulated PhosphateFluoride (Sodium Fluoride and Hydrofluoric Acid) 1.23 w/w fluoride ion.
WARNINGS AND PRECAUTIONS SECTION.
WARNINGS:DO NOT SWALLOWAccidental 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, administercalcium (e.g. milk) and get medical or contact Poison control Center rightaway. One bottle of Minute Foam contained 1.95 grams of fluoride ion whichcould 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 thisproduct.Avoid spraying towards open flame.Contents under pressure. Do not puncture or incinerate. Do not expose to heator store at temperatures over 120 (49 C). PRECAUTIONS: FORPROFESSIONAL USE ONLY Laboratory studies have indicated that repeated use of Acidulated PhosphateFluoride products may dull porcelain and composite restorations. Safety and effectiveness below age have not been established. There have beenno long term studies with this product to evaluate carcinogenic, mutagenic orimpairment of fertility potential.