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POWER WHITE

DENTOVATIONS INC




FULL PRESCRIBING INFORMATION

Active ingredient

ACTIVE INGREDIENTS: SODIUM MONOFLUOROPHOSPHATE 0.88% (W/W)

Purpose

PURPOSE:

ANTI-CAVITY

Uses

USES: HELPS PROTECT AGAINST CAVITIES.

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

FOR THE BEST RESULTS BRUSH TEETH THOROUGHLY, PREFERABLY AFTER EACH MEALOR 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.

Inactive ingredients: calcium pyrophosphate, vegetable glycerin, zea mays (corn) starch, propylene glycol, PEG-12, water, sodium lauryl sulfate, hydrogen peroxide, carbomer, cellulose gum, flavor, potassium acesulfame, piroctone olamine

POWER WHITE

POWER WHITE

POWER WHITE

SODIUM FLUORIDE GEL, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57353-104
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 0.88 g

Inactive Ingredients

Ingredient Name Strength
CALCIUM PYROPHOSPHATE
GLYCERIN
STARCH, CORN
propylene glycol
POLYETHYLENE GLYCOL 600
water
SODIUM LAURYL SULFATE
hydrogen peroxide
CARBOMER 934
CARBOXYMETHYLCELLULOSE SODIUM
ACESULFAME POTASSIUM
PIROCTONE OLAMINE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57353-104-14 113 in 1 TUBE
2 NDC:57353-104-24 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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