ORAL DEFENSE FLUORIDE RINSE- sodium fluoride mouthwash 
Oral Defense, 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.

----------

Oral Defense Fluoride Rinse

Drug Facts

Active Ingredients

Sodium Fluoride .05% (0.22% w/v fluoride ion)

Purpose

Anti-cavity

Uses

Aids in the prevention of dental cavities

Warnings

Do not swallow. In case of accidental ingestion, seek medical help or contact a poison control center immediately. Cold weather may cloud this product. Properties are not affected.

Keep out of the reach of children.

Directions

Adults and children 6 years of age and older

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, flavor, versene, cetylpyridinium chloride, sodium lauroyl sarcosinate, sodium saccharin, sodium hydroxide, citric acid, natamycin, FD and C green #5, FD and C red #33.

Labels

Oral Defense Fluoride Rinse Label

Oral Defense Fluoride 2oz

ORAL DEFENSE FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.2418 g  in 474 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
NATAMYCIN (UNII: 8O0C852CPO)  
MINT (UNII: FV98Z8GITP)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Colorturquoise (Blue green) Score    
ShapeSize
FlavorVANILLA (Vanilla Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52644-002-00474 mL in 1 BOTTLE, PLASTIC
2NDC:52644-002-0260 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/31/2010
Labeler - Oral Defense, LLC (962643164)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture(52644-002)

Revised: 4/2013
Document Id: bc01abf8-ac41-40c1-a4ab-1d4ba7c64a42
Set id: 59a1f399-3609-4eef-b635-1f526cd75819
Version: 12
Effective Time: 20130418
 
Oral Defense, LLC