ZOHAR TOOTHPASTE FRESH MINT- sodium monofluorophosphate paste, dentifrice

Summary of Product characteristics

                                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._
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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
                                
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