LUSTER POWER WHITE DEEP STAIN ERASER- sodium monofluorophosphate gel, dentifrice

LUSTER POWER WHITE by

Drug Labeling and Warnings

LUSTER POWER WHITE by is a Otc medication manufactured, distributed, or labeled by DENTOVATIONS INC, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Sodium Monofluorophosphate 0.88% (w/w)

PURPOSE

PURPOSE: Anti-cavity toothpaste

INDICATIONS & USAGE

USE: Helps protect against cavities

WARNINGS

WARNINGS:

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 12 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away. Avoid contact of the product with the eyes. If irritation (such as redness, swelling or soreness) of the gums or the mouth occurs, discontinue use and consult a dentist.

DOSAGE & ADMINISTRATION

DIRECTIONS: Adults and children 12 years of age and older. For the best results brush teeth thoroughly, preferably after each meal or least twice a day, or as directed by a dentist. Do not swallow. Product is not recommended for use by children under 12 years of age.

STORAGE AND HANDLING

OTHER INFORMATION: Store between 50°F (10°C) and 80°F (27°C)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Calcium Pyrophosphate, Vegetable Glycerin, Zea Mays (Corn) Starch, Propylene Glycol, PEG-12, Water, Sodium Lauroyl Sarcosinate, Hydrogen Peroxide, Carbomer, Cellulose Gum, Flavor, Sodium Saccharin, Piroctone Olamine

QUESTIONS

QUESTIONS OR COMMENTS?

Call 1-800-823-5727 (M-F 9 A.M. - 5 P.M. EST)

visit LusterPowerWhite.com, email: info@lusterpremiumwhite.com or follow: @LusterPremWhite

SPL UNCLASSIFIED SECTION

Dentovations, Inc.

Boston, MA 02116

Made in New England, U.S.A.

PRINCIPAL DISPLAY PANEL

LUSTER PREMIUM WHITE

POWER WHITE

DEEP STAIN ERASER

FLUORIDE TOOTHPASTE

REMOVES UP TO 95% OF SURFACE STAINS IN 5 DAYS

ENAMEL SAFE

PEROXIDE WHITENING

EXCITE-MINT FLAVOR

NET WT. 4 OZ (113 G)

INGREDIENTS AND APPEARANCE

LUSTER POWER WHITE  DEEP STAIN ERASER
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57353-106
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.88 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CARBOMER 934 (UNII: Z135WT9208)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57353-106-53	1 in 1 BOX	12/01/2012
1	NDC: 57353-106-13	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2012

Labeler - DENTOVATIONS INC (128248676)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(57353-106)