FRESHDENT CAVITY PROTECTION ANTICAVITY- sodium monofluorophosphate paste, dentifrice 
FreshDent 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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FreshDent Anticavity Toothpaste

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.085% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of Reach of children

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.

Directions

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Calcium Carbonate, Sodium Lauryl Sulfate,Carboxymethyl Cellulose, Flavor, Titanium Dioxide, Sodium Saccharin, Sodium Methyl Paraben, FD&C Blue 1.

Questions?

+1-512-653-8814

Package Label

Anticavity Toothpaste

FreshDent          

we care      

Cavity Protection

Strengthens teeth with Active Fluoride

Net Wt. 0.85 oz (24 g)

Distributed by: FreshDent LLC Crockett, TX 75835 www.freshdent.net Made in Egypt

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FRESHDENT CAVITY PROTECTION ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69338-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.85 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69338-002-011 in 1 CARTON
124 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/06/2014
Labeler - FreshDent LLC (079303265)
Establishment
NameAddressID/FEIBusiness Operations
Swiss Egyptian Co. For Oral Care Products and Cosmetics366442234manufacture(69338-002)

Revised: 11/2014
Document Id: a5acc4f6-b53f-4a17-a889-ef681cfdf27b
Set id: 16ac653c-0bad-4d3b-a060-1be1444f28af
Version: 1
Effective Time: 20141106
 
FreshDent LLC