SODIUM FLUORIDE AND POTASSIUM NITRATE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O), POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acid, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 1.1% and Potassium Nitrate 5% Sensitive in a squeeze-tube is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste, unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.) Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Product summary:

Store at Controlled Room Temperature, 20°-25°C (68°-77°F)

Authorization status:

unapproved drug other

Summary of Product characteristics

SODIUM FLUORIDE AND POTASSIUM NITRATE- SODIUM FLUORIDE AND POTASSIUM
NITRATE GEL
WESTMINSTER PHARMACEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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SODIUM FLUORIDE 1.1% AND POTASSIUM NITRATE 5% SENSITIVE
Rx Only
_1.1% SODIUM FLUORIDE, 5% POTASSIUM NITRATE_
_PRESCRIPTION STRENGTH TOOTHPASTE FOR SENSITIVE TEETH_
DESCRIPTION
Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium
fluoride and 5%
potassium nitrate.
ACTIVE INGREDIENTS
Sodium Fluoride 1.1% (w/w)
Potassium Nitrate 5%
INACTIVE INGREDIENTS
D&C Yellow No.10, Dicalcium Phosphate, FD&C Blue No.1, Glycerin,
Hydrated Silica, Mint
Flavor, Purified Water, Sodium Benzoate, Sodium Luaryl Sulfate, Sodium
Saccharin,
Sorbitol, Titanium Dioxide, Xanthum Gum.
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
A dental caries preventive and sensitive teeth toothpaste; for twice
daily self-applied
topical use, followed by rinsing. Helps reduce the painful sensitivity
of the teeth to cold,
heat, acid, sweets or contact in adult patients and children 12 years
of age and older. It
is well established that 1.1% sodium fluoride is safe and
extraordinarily effective as a
caries preventive when applied frequently with mouthpiece applicators.
Sodium
Fluoride 1.1% and Potassium Nitrate 5% Sensitive in a squeeze-tube is
easily applied
onto a toothbrush. This prescription toothpaste should be used twice
daily in place of
your regular toothpaste, unless otherwise instructed by your dental
professional. May
be used whether or not drinking water is fluoridated, since topical
fluoride cannot
produce fluorosis. (See WARNINGS for exception.)
1-4
CONTRAINDICATIONS
Do not use in pediatric patients under age 12 ye