FLUORIDEX- sodium fluoride paste, dentifrice

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)

Διαθέσιμο από:

DEN-MAT HOLDINGS, LLC.

Οδός χορήγησης:

DENTAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 6 years of age unless recommended by a dentist or physician. 1 PregnancyPregnancy 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 childho

Περίληψη προϊόντος:

4 oz. (112 g) net wt. tube • Daily Defense Fruit NDC 59883-015-04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only Manufactured for Den-Mat Holding, LLC ©2016 Den-Mat Holdings, LLC 1017 W. Central Ave. All rights reserved Lompoc, CA 93436 reserved752260000 11/16SN

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

FLUORIDEX- SODIUM FLUORIDE PASTE, DENTIFRICE
DEN-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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FLUORIDEX TOOTHPASTE, MINT
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 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 6-16, should expectorate after use and rinse mouth
thoroughly. (2)
• Use twice daily as your normal dentifrice or as directed by your
dental professional. (2)
DOSAGE FORMS AND STRENGTHS______________________________________
• Daily Defense Mint: Green toothpaste containing 1.1% Sodium
Fluoride (Mint). (3)
• Daily Defense Fruit: Pink toothpaste containing 1.1% Sodium
Fluoride (Fruit). (3)
• Enhanced Whitening Mint: Green toothpaste containing 1.1% Sodium
Fluoride (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 6 YEARS OF AGE. If more than
used for brushing is accidentally
swallowed, get medical help or contact a Poison Control Center right
a