FLUORIDEX- sodium fluoride paste, dentifrice

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:

DENT-MAT HOLDINGS, LLC.

INN (International Name):

SODIUM FLUORIDE

Composition:

FLUORIDE ION 5 mg in 1 g

Administration route:

DENTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. Do not use in children under 12 years of age unless recommended by a dentist or physician. 8.1 Pregnancy Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. 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 or well controlled clinical 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 chi

Product summary:

4 oz. (112 g) net wt. tube • Sensitivity Relief NDC 59883-031-04 • Sensitivity Relief SLS Free NDC 59883-030-04 Store at controlled room temperature 15°-30° C (59°-86° F)

Authorization status:

unapproved drug other

Summary of Product characteristics

FLUORIDEX- SODIUM FLUORIDE PASTE, DENTIFRICE
DENT-MAT HOLDINGS, 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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DEN-MAT SENSITIVE (SLS FREE) TOOTHPASTE
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION____________________________
These highlights do not include all the information needed to use
Fluoridex toothpaste
safely and effectively. See full prescribing information.
Fluoridex 1.1% Sodium Fluoride, 5% Potassium Nitrate toothpaste for
oral use
INDICATIONS AND USAGE_______________________________________________
Fluoridex toothpaste is indicated for use as part of a professional
program for the
prevention and control of dental caries. (1)
DOSAGE AND ADMINISTRATION_________________________________________
• Apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to
a toothbrush and
brush thoroughly on all tooth surfaces for at least one minute. (2)
• After use, adults should expectorate. For best results, do not
eat, drink, or rinse for
30 minutes. Children, age 12-16, should expectorate after use and
rinse mouth
thoroughly. (2)
• Children under 12 years of age should consult a dentist or doctor.
• Use twice daily as your normal dentifrice or as directed by your
dental professional. (2)
DOSAGE FORMS AND STRENGTHS______________________________________
• Sensitivity Relief: Green toothpaste containing 1.1% Sodium
Fluoride, 5% Potassium
Nitrate (Mint). (3)
• Sensitivity Relief SLS Free: Green toothpaste containing 1.1%
Sodium Fluoride, 5%
Potassium Nitrate (Mint). (3)
CONTRAINDICATIONS___________________________________________________
Do not use in children under 6 years of age unless recommended by a
dentist or
physician. (4)
WARNINGS AND PRECAUTIONS_________________________________________
● DO NOT SWALLOW. (5)
● Keep out of reach of children under 12 years of age. If more than
used for brushing
is accidental