WHITENING KIT- sodium mfp kit

Whitening Kit by

Drug Labeling and Warnings

Whitening Kit by is a Otc medication manufactured, distributed, or labeled by CVS, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

PURPOSE

Anticavity

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). * supervise children as necessary until capable of using without supervision. * children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

glycerin, hydrated silica, water, sorbitol, pentasodium triphosphate, PVP, titanium dioxide, cellulose gum, flavor, cocamidopropyl betaine, sodium lauryl sulfate, potassium sorbate, sorbic acid, potassium acesulfame, sucralose, sodium hydroxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WHITENING KIT 
sodium mfp kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-410

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-410-09	1 in 1 CARTON; Type 0: Not a Combination Product	11/09/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	76.5 g

Part 1 of 1

WEEKEND WHITE TP 
sodium mfp paste, dentifrice

Product Information
Item Code (Source)	NDC: 51316-411
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
SORBITOL (UNII: 506T60A25R)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCRALOSE (UNII: 96K6UQ3ZD4)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		76.5 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 Drug	M021	11/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	11/09/2021

Labeler - CVS (062312574)

Registrant - Lornamead (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		080046418	manufacture(51316-410) , pack(51316-410)