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.: Int. J. Cancer 48, 733-737 (1991) (5.) Maurer, J.K. et al.: J. Natl. Cancer Inst. 82, 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 Fluoride (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.
NEUTRA-FOAMFoaming Solution(2.0% w/w Neutral Sodium Fluoride) FOR PROFESSIONAL USEONLY ActiveIngredient:Sodium Fluoride 2.0%w/w (0.9% or 9048 ppm fluoride ion).
WARNINGS AND PRECAUTIONS SECTION.
WARNINGS:DO NOT SWALLOW.o Accidental ingestion of the usual treatment dose (approximately 9.0 mg offluoride) is not harmful. In the event more than the treatment dose isswallowed, administer calcium (e.g. milk) and get medical or contact Poisoncontrol Center right away. One bottle of Neutra-Foam contains 1.43 grams offluoride ion which could be lethal for children and adults.o Keep out of the reach of infants and children under 12 years.o Pediatric patients under 12 years of age should be supervised during use ofthis product.o Avoid spraying towards open flame.o Contents under pressure. Do not puncture or incinerate. Do not expose to heator store at temperatures over 120F (49C). PRECAUTIONS:FOR PROFESSIONAL USE ONLY.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.
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. In patients with mucositis, gingival tissues may be hypersensitive tothe flavor.
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 rats (3,4). In another study, no carcinogenicity was observed in ratstreated with fluoride up to 25 mg/kg of body weight (5). Overall,epidemiological studies do not show an association between fluoridated drinkingwater and increased cancer risk in humans (7).Fluoride ion is not mutagenic in standardbacterial systems but has been associated with genetic aberrations in culturedhuman cells at doses much higher than expected for human exposure (6,8). Somein vivo studies report chromosomal aberrations in rodents while other studiesusing similar protocols report 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: Sodium Fluoride inhibits caries formation byreducing enamel solubility and enhancing remineralization.
CONTRAINDICATIONS: Do not use in patients with hypersensitivityto fluoride. Do not use in patients with dysphagia.
DESCRIPTION:Oral-BNeutra-Foam is mint flavored neutral aqueous foaming solution of 2.0% w/wsodium fluoride.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Adults and Children years and over: Use foam times year. The initial time you dispense from new bottle, gently lift upward on the nozzle to break the protective seal (thin plastic tab located adjacent to trigger). If this seal is broken do not use product. When breaking this seal, there could be an initial surge of foam from the dispenser. Shake bottle vigorously for 3-4 seconds prior to dispensing.o Invert bottle 180 with nozzle tip pointed downward into tray.o 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. (Note: foam will expand slightly to fill the tray.)o Do not use excessive finger pressure which could result in too much foam being dispensed.o Immediately place tray(s) in mouth. (Note: Do not fill trays with foam too far in advance of treatment as the foam will collapse and not be as effective.)o Have patient bite down on the tray(s) lightly but firmly for up to minutes.o Remove tray(s) and have patient expectorate.o 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). You can choose from single arch trays (such as CENTRAYS) or dual arch trays (CENTWINS or SOFTWINS).
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.
HOW SUPPLIED SECTION.
HOWSUPPLIED: Neutra-Foam is available in 5.8 oz (165 g) plasticaerosol container in mint flavor. NDC 0041-0348-06.
INACTIVE INGREDIENT SECTION.
InactiveIngredients:Purifiedwater, Poloxamer 407, Isobutane, Poloxamer 234, Spearmint flavor, Potassiumphosphate, Sodium saccharin, Methylparaben, Sodium hydroxide, Propylparaben.
INDICATIONS & USAGE SECTION.
INDICATIONAND USE:A topically appliedfoaming solution primarily suited for patients with extensive aestheticrestorations 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 very 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.
OVERDOSAGE:Accidental ingestion of large amounts of fluoride can result in acuteirritation of the mouth and gastrointestinal tract as well as the developmentof gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesisepigastric cramping and abdominal pain. If large amount of fluoride equal toor greater than mg fluoride/kg body weight (2.3 mg fluoride/lb body weight)is ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium solution)orally to relieve gastrointestinal symptoms and admit immediately to hospitalfacility. standard treatment dose of Neutra-Foam contains approximately 9.0mgfluoride. One 165 (5.8 oz) bottle contains approximately 1.43 of fluoride.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Minute Foam Label Image of Label.
PEDIATRIC USE SECTION.
Pediatricuse: The use of fluoride solutions, gels, and foamscontaining up to 1.23 fluoride ion as caries preventives in pediatric patientsaged to 16 years is supported by clinical studies in students aged to 12years (1,2). Safety and effectiveness in pediatric patients below the age of 6years has not been established. Please refer to CONTRAINDICATIONS and WARNINGSsections.
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.