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Spl Patient Package Insert
(2.0% w/w Neutral Sodium Fluoride)FOR PROFESSIONAL USE
Ingredient:Sodium Fluoride 2.0%
w/w (0.9% or 9048 ppm fluoride ion)
Neutra-Foam is a mint flavored neutral aqueous foaming solution of 2.0% w/w
water, Poloxamer 407, Isobutane, Poloxamer 234, Spearmint flavor, Potassium
phosphate, Sodium saccharin, Methylparaben, Sodium hydroxide, Propylparaben.
PHARMACOLOGY: Sodium Fluoride inhibits caries formation by
reducing enamel solubility and enhancing remineralization.
Indications & Usage
AND USE:A topically applied
foaming solution primarily suited for patients with extensive aesthetic
restorations to aid in the prevention of dental caries.
CONTRAINDICATIONS: • Do not use in patients with hypersensitivity
to fluoride. • Do not use in patients with dysphagia.
Warnings And Precautions
DO NOT SWALLOW.
• Accidental ingestion of the usual treatment dose (approximately 9.0 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 Neutra-Foam contains 1.43 grams of
fluoride ion which could be lethal for children and adults.
• Keep out of the reach of infants and children under 12 years.
• Pediatric patients under 12 years of age should be supervised during use of
• 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.
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.
Carcinogenesis & Mutagenesis & Impairment Of Fertility
Mutagenesis, Impairment of Fertility:
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 rats (3,4). In another study, no carcinogenicity was observed in rats
treated with fluoride up to 25 mg/kg of body weight (5). Overall,
epidemiological studies do not show an association between fluoridated drinking
water and increased cancer risk 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).
Effects: Pregnancy Category B. Fluoride readily crosses the
placenta (7,9). Animal studies (rats and rabbits) have shown that fluoride is
not a teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of body
weight did not affect maternal body weight, litter size or fetal weight and did
not increase frequency of skeletal or visceral malformations (10). There are no
adequate and well-controlled studies in pregnant women. Several epidemiological
studies show no increase in birth defects in areas with fluoridated water
compared to areas with low fluoridated water (7). However, caution should be exercised
when fluoride is administered to pregnant women.
mothers: Due to the relative insensitivity of human milk
fluoride levels to changes in maternal fluoride intake, and due to the very low
concentrations of fluoride in human milk, fluoride supplementation during
lactation would not be expected to significantly affect fluoride intake by the
nursing infant (11). However, caution should be exercised when fluoride is
administered to nursing women.
use: The use of fluoride solutions, gels, and foams
containing up to 1.23 % fluoride ion as caries preventives in pediatric patients
aged 6 to 16 years is supported by clinical studies in students aged 6 to 12
years (1,2). Safety and effectiveness in pediatric patients below the age of 6
years has not been established. Please refer to CONTRAINDICATIONS and WARNINGS
use: No overall differences in safety or effectiveness
have been observed between geriatric and younger patients. This drug is known
to be substantially excreted by the kidney, therefore the risk of toxic
reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care
should be taken in dose selection, and it may be useful to monitor renal
REACTIONS: Developing teeth of children under age 6 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. In patients with mucositis, gingival tissues may be hypersensitive to
Accidental ingestion of large amounts of fluoride can result in acute
irritation of the mouth and gastrointestinal tract as well as the development
of gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis
epigastric cramping and abdominal pain. If a large amount of fluoride equal to
or greater than 5 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 a hospital
facility. A standard treatment dose of Neutra-Foam contains approximately 9.0mg
fluoride. One 165 g (5.8 oz) bottle contains approximately 1.43 g of fluoride.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over: Use foam 2 times a year. The initial time you dispense from a 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.• Invert bottle 180° 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. (Note: foam will expand slightly to fill the tray.)• Do not use excessive finger pressure which could result in too much foam being dispensed.• 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.)• Have patient bite down on the tray(s) lightly but firmly for up to 4 minutes.• Remove tray(s) and have patient expectorate.• 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). You can choose from single arch trays (such as CENTRAYS) or dual arch trays (CENTWINS or SOFTWINS).
SUPPLIED: Neutra-Foam is available in a 5.8 oz (165 g) plastic
aerosol container in mint flavor. NDC 0041-0348-06.
REFERENCES:(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.: 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
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