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Oral Defense by Oral Defense, LLC

Medically reviewed on May 18, 2018

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE .47mL in 474mL
Labeler: Oral Defense, LLC
NDC Code: 52644-001

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 Mouth Rinse

Drug Facts

Active Ingredients

Cetylpyridinium Chloride 0.1%

Pupose

Antigingivitus/Anti-Plaque

Uses
  • Canker sores
  • Dry mouth conditions
  • Oral lesions from chemo and radiation therapies
  • Diabetes
  • Gum irritations and disease
  • Lichen Plannus

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

ORAL DEFENSE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE.47 mL  in 474 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
EDETATE DISODIUM 
POLOXAMER 407 
PROPYLENE GLYCOL 
SORBITOL 
SACCHARIN SODIUM 
GLYCERIN 
POLYSORBATE 80 
NATAMYCIN 
SODIUM LAUROYL SARCOSINATE 
PEPPERMINT OIL 
MENTHOL 
SODIUM HYDROXIDE 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Colorturquoise (Blue/Green) Score    
ShapeSize
FlavorMINT (Cool mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Coastal Products Company782445688manufacture(52644-001)

 
Oral Defense, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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