Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
SKYLINE HERBALS PRIVATE LIMITED
DENTAL
OTC DRUG
Anticavity Toothpaste aids in the prevention of dental cavities
OTC monograph final
SKYLINE HERBALS- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE SKYLINE HERBALS PRIVATE LIMITED _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._ ---------- SKYLINE FLUORIDE TOOTHPASTE DRUG FACTS Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion) PURPOS E Anticavity Toothpaste US E aids in the prevention of dental cavities _WARNING_ Keep out of reach of children under 6 years of age _WARNING_ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control center immediately DIRECTIONS Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) 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 physician CHILDREN UNDER 6 YEARS OF AGE: Do not use unless directed by a dentist or physician OTHER INFORMATION Store at 59°-86°F (15°-30°C) Avoid excessive heat INACTIVE INGREDIENTS Calcium Carbonate, Water, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Sodium Carboxymethyl Cellulose, Flavor, Sodium Saccharin, Sodium Methyl Paraben, Sodium Propyl Paraben PRINCIPAL DISPLAY PANEL - 43 G TUBE CARTON SKYLINE HERBALS sodium monofluorophosphate paste, dentifrice PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:8 0 239 -9 138 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRE NG TH STRE NG TH SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 7.6 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) WATER (UNII: 0 59 QF0 KO0 R) SO RBITO L (UNII: 50 6 T6 0 A25R) HYDRATED SILICA (UNII: Y6 O7T4G8 P9 ) SO DIUM LAURYL SULFATE (UNII: 36 8 Læs hele dokumentet