SODIUM FLUORIDE- sodium fluoride rinse 
Vi-Jon

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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971.001  971AB
Fluoride Anti-Cavity Mouthwash

Active Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

for this product

Keep out of reach of children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

Adults and children 6 years of age and older:

Other information

Inactive ingredients

water, sorbitol solution, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

principal display panel

Anticavity Mouthwash

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 L)

971.000/971AA

image description

SODIUM FLUORIDE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0971
Route of AdministrationOral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/11/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/11/2013
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(0869-0971)

Revised: 10/2020
Document Id: 8a20c761-0443-4eec-99b1-e5cc8f8e2e6b
Set id: 25b10a42-e66d-4ef1-92e5-0d2261bdb482
Version: 5
Effective Time: 20201005
 
Vi-Jon