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DENTOVATIONS INC




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENT: SODIUM FLUORIDE 0.24% (W/W)

Purpose

PURPOSE:

ANTI-CAVITY

Uses

USES: ANTI-CAVITY.

DIRECTIONS: ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER:

FOR THE BEST RESULTS BRUSH TEETH THOROUGHLY, PREFERABLY AFTER EACH MEAL OR AT LEAST TWICE A DAY, OR AS DIRECTED BY A DENTIST OR DOCTOR. DO NOT SWALLOW. PRODUCT IS NOT RECOMMENDED FOR USE BY CHILDREN UNDER 12 YEARS OF AGE.

KEEP OUT OF REACH OF CHILDREN UNDER 12 YEARS.

WARNINGS: IF MORE THAN THE AMOUNT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY. AVOID CONTACT OF THE PRODUCT WITH THE EYE. IF IRRITATION (SUCH AS REDNESS, SWELLING, SORENESS) OF THE GUM OR THE MOUTH OCCURS, DISCONTINUE USE AND CONSULT A DENTIST.

OTHER INFORMATION: STORE BETWEEN 59-80°F (15-27°C).

INACTIVE INGREDIENTS: Sorbitol, Silica, Water, Propylene Glycol, Sodium Lauryl Sulfate, Flavor, Disodium Phosphate, PVM/MA Copolymer,

Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Xanthan Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, FD&C Blue No. 1

QUESTIONS OR COMMENTS?

1-800-823-5727  *  M-F  9 A.M. - 5 P.M. EST  *  LUSTERPREMIUMWHITE.COM

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SODIUM FLUORIDE GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57353-103
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION .24 g

Inactive Ingredients

Ingredient Name Strength
sorbitol
HYDRATED SILICA
water
propylene glycol
SODIUM LAURYL SULFATE
sodium phosphate
POLYVINYL ALCOHOL
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM BENZOATE
ACESULFAME POTASSIUM
XANTHAN GUM
SODIUM PYROPHOSPHATE
titanium dioxide
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57353-103-13 113 in 1 TUBE
2 NDC:57353-103-53 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2012-12-01


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