Country: United States
Language: English
Source: NLM (National Library of Medicine)
Sodium monofluorphosphate 1.15% (1500ppm/ 0.15% w/v fluoride ion)
Broom Lane Enterprises
DENTAL
OTC DRUG
Anticavity Aids in the prevention of dental cavities
OTC monograph final
ZOHAR TOOTHPASTE FRESH MINT- SODIUM MONOFLUOROPHOSPHATE PASTE, DENTIFRICE BROOM LANE ENTERPRISES _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._ ---------- DRUG FACTS ACTIVE INGREDIENTS Sodium monofluorphosphate 1.15% (1500ppm/ 0.15% w/v fluoride ion) PURPOS E Anticavity US ES 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 do not swallow supervise children as necessary until capable of using without supervision. 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 6 to 12 years instruct in good brushing and rinsing habits(to minimise swallowing) children under 6 years do not use unless directed by dentist or doctor Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene QUES TIONS ? call 718 256 9100 you may also report serious side effects to this phone number PRINCIPAL DISPLAY PANEL ZOHAR FLUORIDE TOOTHPASTE FRESH MINT HELPS FIGHT TOOTH DECAY Net Wt. 4oz/75ml ZOHAR TOOTHPASTE FRESH MINT sodium monofluorophosphate paste, dentifrice PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:55754-121 ROUTE OF ADMINISTRATION DENTAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) SODIUM MONOFLUOROPHOSPHATE 11.5 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) GLYCERIN (UNII: PDC6 A3C0 OX) HYDRATED SILICA (UNII: Y6 O7T4G8 P9 ) SO DIUM LAURYL S Read the complete document