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Name:Advanced Fluoride Anticavity Fluoride Toothpaste
Manufacturer:Personal Care Products, Llc
Category:Over-the-counter (OTC) Marketed Drugs


ADVANCED FLUORIDE ANTICAVITY TOOTHPASTE

ADVANCED FLUORIDE ANTICAVITY FLUORIDE TOOTHPASTE  - sodium monofluorophosphate paste, dentifrice 
Personal Care Products, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ADVANCED FLUORIDE ANTICAVITY TOOTHPASTE

Active Ingredent

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of cavities

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 under 6 yrs of age.

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 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.


CAVITY FIGHTING TOOTHPASTE

Distributed by:

Personal Care Products, LLC

Bingham Farms, MI 48025-2463

Made in China

Advanced Fluoride Anticavity Toothpaste

New Ultra Breath Freshener Stripe

Net Wt 6.4oz (181g)

Multi
Protection

Fights Cavities

Freshens Breath

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste

Advanced Whitening Toothpaste


ADVANCED FLUORIDE ANTICAVITY FLUORIDE TOOTHPASTE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:29500-0819
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
POWDERED CELLULOSE  
GLYCERIN  
ALUMINUM OXIDE  
HYDRATED SILICA  
POTASSIUM SORBATE  
SACCHARIN SODIUM  
SODIUM LAURYL SULFATE  
SORBITAN MONOOLEATE  
SORBITOL  
TITANIUM DIOXIDE  
WATER  
XANTHAN GUM  
FD&C BLUE NO. 1  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29500-0819-6 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 181 g in 1 TUBE This package is contained within the BOX (29500-0819-6)

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)

Revised: 01/2011 Personal Care Products, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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