Oral Defense Fluoride Rinse

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE .2418g in 474mL
Labeler: Oral Defense, LLC
NDC Code: 52644-002

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

  • Use once a day, preferably before bedtime, after brushing and flossing thoroughly.
  • For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.
  • Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.
  • Supervise children over 6 years of age until capable of suing without supervision.
  • Consult with a dentist or doctor for use with children under 6 years of age.
  • Do not take in food or drink for 30 minutes after application.

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 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52644-002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION.2418 g  in 474 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
EDETATE DISODIUM 
POLOXAMER 407 
PROPYLENE GLYCOL 
CETYLPYRIDINIUM CHLORIDE 
SORBITOL 
SACCHARIN SODIUM ANHYDROUS 
GLYCERIN 
POLYSORBATE 80 
NATAMYCIN 
MINT 
SODIUM LAUROYL SARCOSINATE 
SODIUM HYDROXIDE 
CITRIC ACID MONOHYDRATE 
Product Characteristics
Colorturquoise (Blue green) Score    
ShapeSize
FlavorVANILLA (Vanilla Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Coastal Products Company782445688manufacture(52644-002)

Revised: 04/2013
 
Oral Defense, LLC

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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