Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
DEN-MAT HOLDINGS, LLC.
DENTAL
PRESCRIPTION DRUG
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. 8.1 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 child
4 oz. (112 g) net wt. tube • Daily Defense Mint NDC 59883-016-04 • Daily Defense Fruit NDC 59883-015-04 • Enhanced Whitening Mint NDC 59883-020-04 Store at controlled room temperature 15°-30° C (59°-86° F) Rx Only
unapproved drug other
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._ ---------- DEN-MAT - ENHANCED WHITENING, CLEAN MINT 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 away. (5) ● Repeated ingestion of high levels of fl Belgenin tamamını okuyun