ADVANCED WHITENING ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

Advanced Whitening Anticavity Fluoride by

Drug Labeling and Warnings

Advanced Whitening Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, LLC, Yangzhou Lierkang Daily Used Chemicals Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredent

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose

Anticavity toothpaste

INDICATIONS & USAGE

Use

Aids in the prevention of cavities

WARNINGS

If more than is used for brushing is accidentally swallowed get medical help or contact a poison control center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 yrs of age.

DOSAGE & ADMINISTRATION

Directions

adults and children 2 years. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.

do not swallow

to minimize swallowing, use a pea-sized amount in children under 6 years old

supervise children's brushing until good habits are established

children under 2y ears: ask a dentist before use.

INACTIVE INGREDIENT

Inactive ingredients-

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

SPL UNCLASSIFIED SECTION

Distributed by:

Personal Care Products, LLC

Bingham Farms, MI 48025-2463

Made in China

PRINCIPAL DISPLAY PANEL

Advanced Whitening Anticavity Fluoride Toothpaste

Net Wt 6.4oz (181g)

Fresh Mint

Fights Tarter Build-up

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED WHITENING ANTICAVITY FLUORIDE  
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2238
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2238-6	1 in 1 BOX
1		181 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/24/2011

Labeler - Personal Care Products, LLC (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Lierkang Daily Used Chemicals Co Ltd		531075083	manufacture