Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
EMAG AG
SODIUM FLUORIDE
FLUORIDE ION 0.16 g in 100 g
DENTAL
OTC DRUG
Anticavity Aids in the prevention of dental cavities.
OTC monograph final
EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD- SODIUM FLUORIDE PASTE, DENTIFRICE EMAG AG _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._ ---------- EMMI DENT SODIUM FLUORIDE ANTICAVITY TOOTHPASTE EMMI DENT SODIUM FLUORIDE ANTICAVITY TOOTHPASTE MILD ACTIVE INGREDIENT Sodium fluoride 0.243% (0.16 w/v fluoride ion) PURPOS E Anticavity US E Aids in the prevention of dental 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. DIRECTIONS Adults and children 2 years 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: Consult a dentist or doctor. INACTIVE INGREDIENTS water, hydrated silica, sorbitol, propylene glycol, tetrapotassium pyrophosphate, xanthan, gum, sodium C14-16 olefin sulfonate, flavor, titanium dioxide, sodium methylparaben, sodium saccharin, allantoin, limonene, chamomile (chamomilla recutita) flower extract, three-lobe sage (salvia triloba) leaf extract, citral REPRESENTATIVE LABELING EMMI DENT SODIUM FLUORIDE ANTICAVITY MILD sodium fluoride paste, dentifrice PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 39 56 -0 0 1 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 0 .16 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) HYDRATED SILICA (UNII: Y6 O7T4G8 P9 ) EMAG AG SO RBITO L (UNII: 50 6 T6 0 A25R) PRO PYLENE GLYCO L (UNII: 6 DC9 Q1 Lees het volledige document