Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Dental Alliance Holdings LLC
SODIUM FLUORIDE
FLUORIDE ION 1100 ug in 1 g
DENTAL
OTC DRUG
Anticavity Aids in the prevention of dental caries (cavities)
OTC monograph final
CTX4 GEL 1100 MINT- SODIUM FLUORIDE GEL, DENTIFRICE CTX4 GEL 1100 CITRUS- SODIUM FLUORIDE GEL, DENTIFRICE CTX4 GEL 1100 GRAPE- SODIUM FLUORIDE GEL, DENTIFRICE DENTAL ALLIANCE HOLDINGS LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- GEL 1100 ACTIVE INGREDIENTS: Sodium Fluoride 0.24% PURPOSE: Anticavity USE: Aids in the prevention of dental caries (cavities) WARNINGS: 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. WARNINGS: 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. DIRECTIONS: ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor. INACTIVE INGREDIENTS: Glycerin, Hydrated Silica, Hydrogenated Starch Hydrolysate (HSH), Hydroxyapatite, Hydroxyethyl Cellulose, Menthol (Mint only), Natural Flavors, Artificial Flavors (Citrus and Grape only) Polysorbate 20, Potassium Sorbate, Saccharin, Sodium Benzoate, Sodium Bicarbonate, Sodium Hydroxide, Sodium Lauryl Sulfate, Water, Xylitol CTX4 GEL 1100 MINT, CITRUS, AND GRAPE ENCLOSURE AND CARTON LABELS: CTX4 GEL 1100 MINT sodium fluoride gel, dentifrice PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:61578-203 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION Citiți documentul complet