FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH- sodium fluoride 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 Kids Strawberry Anticavity Toothpaste

Active Ingredients

Sodium Fluoride 0.188% (0.065% w/v fluoride ion)

Purpose

Anticavity

Use

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, Glycerin, Water,Silica, Carboxymethyl Cellulose, Lauryl Sulfate, Sodium Saccharin, Diazolidinyl Urea, Strawberry Flavor, Menthol, D &C Red No. 33.

Questions?

+1-512-653-8814

Package Label

Strawberry Anticavity toothpaste

FreshDent           Kids

we care

Net Wt. 0.85 oz (24 g)

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

Box

Tube

FRESHDENT KIDS STRAWBERRY ANTICAVITY TOOTH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69338-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.65 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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
MENTHOL (UNII: L7T10EIP3A)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69338-001-011 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(69338-001)

Revised: 11/2014
Document Id: 7ac8f3c3-5c15-44fe-9b13-6f5af2c174f0
Set id: d891b45d-d0a0-4f97-ba42-b7c85765f494
Version: 1
Effective Time: 20141106
 
FreshDent LLC