1.1% Sodium Fluoride Prescription
Adult fluoride toothpaste to prevent tooth decay and reduce tooth sensitivity
Spearmint Twin Pack
Two 1.8 oz. Tubes
insure successful results following periodontal treatments, patient
cooperation in maintaining excellent oral hygiene is essential.
Self-topical neutral fluoride dentifrice
containing 1.1% (w/w) sodium fluoride for use as a dental
caries preventive in adults and pediatric patients.
Sodium fluoride 1.1% (w/w)
Purified water, sorbitol, hydrated silica,
PEG-12, tetrapotassium pyrophosphate, sodium lauryl sulfate,
mint flavor (Spearmint flavor only), xanthan gum, sodium
benzoate, fruit flavor (FruitasticTM* flavor
only), sodium saccharin, titanium dioxide (FruitasticTM*
flavor only), FD&C Blue #1 (Spearmint flavor only),
D&C Red #33 (FruitasticTM* flavor only).
Frequent topical applications to the teeth
with preparations having a relatively high fluoride content
increase tooth resistance to acid dissolution and enhance
penetration of the fluoride ion into tooth enamel.
A dental caries preventive; for once daily
self-applied topical use. It is well established that 1.1%
sodium fluoride is safe and extraordinarily effective as a
caries preventive when applied frequently with mouthpiece
PreviDent 5000 Plus brand of 1.1% sodium fluoride in a
squeeze-tube is easily applied onto a toothbrush. This
prescription dental cream should be used once daily in place
of your regular toothpaste unless otherwise instructed by
your dental professional. May be used in areas where
drinking water is fluoridated since topical fluoride cannot
produce fluorosis. (See WARNINGS for
Do not use in pediatric patients under age
6 years unless recommended by a dentist or physician.
Prolonged daily ingestion may result in
various degrees of dental fluorosis in pediatric patients
under age 6 years, especially if the water fluoridation
exceeds 0.6 ppm, since younger pediatric patients frequently
cannot perform the brushing process without significant
swallowing. Use in pediatric patients under age 6 years
requires special supervision to prevent repeated swallowing
of dental cream, which could cause dental fluorosis. Read
directions carefully before using. Keep out of reach of
infants and children.
Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
In a study conducted in rodents, no carcinogenesis was found
in male and female mice and female rats treated with
fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of
body weight. Equivocal evidence of carcinogenesis was
reported in male rats treated with 2.5 and 4.1 mg/kg of body
weight. In a second study, no carcinogenesis was observed in
rats, males or females, treated with fluoride up to 11.3
mg/kg of body weight. Epidemiological data provide no
credible evidence for an association between fluoride,
either naturally occurring or added to drinking water, and
risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems.
It has been shown that fluoride ion has potential to induce
chromosome aberrations in cultured human and rodent cells at
doses much higher than those to which humans are exposed. In
vivo data are conflicting. Some studies report
chromosome damage in rodents, while other studies using
similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure
in humans has not been adequately evaluated. Adverse effects
on reproduction were reported for rats, mice, fox, and
cattle exposed to 100 ppm or greater concentrations of
fluoride in their diet or drinking water. Other studies
conducted in rats demonstrated that lower concentrations of
fluoride (5 mg/kg of body weight) did not result in impaired
fertility and reproductive capabilities.
It has been shown that fluoride crosses the placenta of
rats, but only 0.01% of the amount administered is
incorporated in fetal tissue. Animal studies (rats, mice,
rabbits) have shown that fluoride is not a teratogen.
Maternal exposure to 12.2 mg fluoride/kg of body weight
(rats) or 13.1 mg/kg of body weight (rabbits) did not affect
the litter size or fetal weight and did not increase the
frequency of skeletal or visceral malformations. There are
no adequate and well-controlled studies in pregnant women.
However, epidemiological studies conducted in areas with
high levels of naturally fluoridated water showed no
increase in birth defects. Heavy exposure to fluoride during
in utero development may result in skeletal
fluorosis, which becomes evident in childhood.
It is not known if fluoride is excreted in human milk.
However, many drugs are excreted in milk, and caution should
be exercised when products containing fluoride are
administered to a nursing woman. Reduced milk production was
reported in farm-raised fox when the animals were fed a diet
containing a high concentration of fluoride (98-137 mg/kg of
body weight). No adverse effects on parturition, lactation,
or offspring were seen in rats administered fluoride up to 5
mg/kg of body weight.
The use of PreviDent 5000 Plus in pediatric groups age 6 to
16 years as a caries preventive is supported by pioneering
clinical studies with 1.1% sodium fluoride gels in mouth
trays in students age 11 to 14 years conducted by Englander
et. al. 2-4 Safety and
effectiveness in pediatric patients below the age of 6 years
have not been established. Please refer to the
CONTRAINDICATIONS and WARNINGS sections.
Allergic reactions and other
idiosyncrasies have been rarely reported.
Accidental ingestion of large amounts of
fluoride may result in acute burning in the mouth and sore
tongue. Nausea, vomiting, and diarrhea may occur soon after
ingestion (within 30 minutes) and are accompanied by
salivation, hematemesis, and epigastric cramping abdominal
pain. These symptoms may persist for 24 hours. If less than
5 mg fluoride/kg body weight (i.e., less than 2.3 mg
fluoride/lb body weight) have been ingested, give calcium
(e.g., milk) orally to relieve gastrointestinal symptoms and
observe for a few hours. If more than 5 mg fluoride/kg body
weight (i.e., more than 2.3 mg fluoride/lb body weight) have
been ingested, induce vomiting, give orally soluble calcium
(e.g., milk, 5% calcium gluconate or calcium lactate
solution) and immediately seek medical assistance. For
accidental ingestion of more than 15 mg fluoride/kg of body
weight (i.e., more than 6.9 mg fluoride/lb body weight),
induce vomiting and admit immediately to a hospital
A treatment dose (a thin ribbon) of PreviDent 5000 Plus
contains 2.5 mg fluoride. A 1.8 oz. tube contains 255 mg
Follow these instructions unless otherwise
instructed by your dental professional:
- Adults and pediatric patients 6 years
of age or older: Apply a thin ribbon of PreviDent 5000
Plus to a toothbrush. Brush thoroughly once daily for
two minutes, preferably at bedtime.
- After use, adults expectorate. For best
results, do not eat, drink, or rinse for 30 minutes.
Pediatric patients, age 6-16, expectorate after use and
rinse mouth thoroughly.
|1.8 oz. (51g) net wt. tubes
Spearmint - NDC 0126-0287-66
FruitasticTM - NDC 0126-0288-66
|Twin Pack (two 1.8 oz. (51g) net wt.
Spearmint - NDC 0126-0287-33
Store at Controlled Room Temperature,
American Dental Association, Accepted Dental Therapeutics
Ed. 40 (Chicago, 1984): 405-407.
2. H.R. Englander et al., JADA 75 (1967): 638-644.
3. H.R. Englander et al., JADA 78 (1969): 783-787.
4. H.R. Englander et al., JADA 83 (1971): 354-358
February 06, 2008