ORAL DEFENSE- sodium fluoride paste, dentifrice 
Oral Defense

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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Drug Facts

Purpose

Anti-Cavity toothpaste

Active Ingredient

Sodium Fluoride 0.25% (0.14 w/v Fluoride Ion)

Use

Aids in prevention of dental cavities and gingivitis.

Warnings

Children under two years of age: Consult a dentist or physician. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of the reach of children under 6 years of age.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a 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.

For maximum benefits, brush for 1 minute at bedtime and use with Oral Defense Fluoride Rinse.

Question and Comments?

1-800-355-9621 • 1-509-326-6693 Office

Manufactured for: Oral Defense LLC, P.O. Box 8267 Spokane, WA 99203

Patent No. US 6,861,047B

Inactive Ingredients

Sorbitol, Purified Water, Glycerin, Hydrated Silica, Sodium Lauroyl Sarconsinate, Cellulose Gum, Flavor, Titanium Dioxide, Cetylpyridinium Chloride, Citric Acid, Sodium Saccharin, FD&C Blue No. 1, Dehydroacetic Acid.

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ORAL DEFENSE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.14 g  in 118 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CETYLPYRIDINIUM (UNII: CUB7JI0JV3)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
Product Characteristics
Colorblue (blue (FD and C Blue No. 1)) Score    
ShapeSize
FlavorMINT (MINT (Fluoride Toothpaste Flavor Mint)) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52644-003-011 in 1 BOX
1NDC:52644-003-00118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/12/2011
Labeler - Oral Defense (962643164)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture(52644-003)

Revised: 1/2013
Document Id: d9a9c8ea-b2da-4f23-ad65-23b174df6f9d
Set id: 4cf196f6-a726-4879-a4d8-7e0c08c0a7a9
Version: 3
Effective Time: 20130105
 
Oral Defense