NDC 0041-0346 Oral-b Minute-foam Strawberry

Spl Patient Package Insert

MINUTE-FOAM
Topical Fluoride
Foaming Solution
(Acidulated Phosphate Fluoride Containing 1.23 % w/w Fluoride Ion)FOR PROFESSIONAL USE
ONLYActive
Ingredient:Acidulated Phosphate
Fluoride (Sodium Fluoride and Hydrofluoric Acid) 1.23 % w/w fluoride ion.

Description

DESCRIPTION:Oral-B
Minute Foam is a flavored aqueous foaming solution of acidulated phosphate
sodium fluoride with pH of 3.5 and a fluoride ion concentration of 1.23% w/w.

Inactive Ingredient

Inactive
Ingredients:Purified
water, poloxamer 407, isobutane, poloxamer 234, phosphoric acid, sodium
saccharin, flavor.

Clinical Pharmacology

CLINICAL
PHARMACOLOGY: Acidulated Phosphate Fluoride inhibits caries
formation by reducing enamel solubility and enhancing remineralization.

Indications & Usage

INDICATION
AND USE:A topically-applied
foaming solution to aid in the prevention of dental caries.

Contraindications

CONTRAINDICATIONS:      Do not use in patients with hypersensitivity
to fluoride.
               
                 
        Do not use in patients with
dysphagia.

Warnings And Precautions

WARNINGS:
DO NOT SWALLOW
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.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis,
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 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).

Pregnancy

Pregnancy:Teratogenic
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.

Nursing Mothers

Nursing
Mothers: Due to the relative insensitivity of human milk
fluoride levels to changes in maternal fluoride intake, and due to the 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.

Pediatric Use

Pediatric
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 sections.

Geriatric Use

Geriatric
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
function.

Adverse Reactions

ADVERSE
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

Overdosage

OVERDOSAGE: Accidental ingestion of large amounts of fluoride can result in acute irritation of the mouth and gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastric cramping and abdominal pain. If large amounts of fluoride equal to or greater than 5mg fluoride/kg body weight (or 2.3 mg fluoride/lb body weight) are ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium lactate solution) orally to relieve gastrointestinal symptoms and admit immediately to a hospital facility.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.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over: Use foam 2 times a year.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

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.

References

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.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