ORAL DEFENSE- cetylpyridinium chloride 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.

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Oral Defense Mouth Rinse

Drug Facts

Active Ingredients

Cetylpyridinium Chloride 0.1%

Pupose

Antigingivitus/Anti-Plaque

Uses

Warnings

See a dentist if symptoms or conditions persist after regular use.

Keep out of the reach of children

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.

Directions

Healthy Mouth

Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue.

Red, Bleeding gums and inflamed mouth

For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over the lesion for 1 minute, or if not possible to hold for 1 minute then use twice, 1 capful for 30 seconds each before spitting out. The most critical time of application is at bedtime, when no food or water is to be consumed after use, as the rinse has ingredients that have a long effective residual throughout the night when healing is best to occur.

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, mentha piperita (peppermint oil), versene, sodium lauroyl sarcosinate, sodium hydroxide, citric acid, menthol, natamycin, FD and C green #5

Questions or comments

1-800-355-9621

Manufactured Exclusively for Oral Defense, LLC Spokane, WA 99205

Labeling

MM1

MM2

ORAL DEFENSE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.47 mL  in 474 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
NATAMYCIN (UNII: 8O0C852CPO)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
Colorturquoise (Blue/Green) Score    
ShapeSize
FlavorMINT (Cool mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52644-001-00474 mL in 1 BOTTLE, PLASTIC
2NDC:52644-001-0260 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/26/2010
Labeler - Oral Defense, LLC (962643164)
Establishment
NameAddressID/FEIBusiness Operations
Coastal Products Company782445688manufacture(52644-001)

Revised: 5/2012
Document Id: 5acd8ebf-2b8e-40d6-a76d-7bad43ff0658
Set id: 561be134-46d3-416c-becd-1d33388ddd2b
Version: 17
Effective Time: 20120518
 
Oral Defense, LLC