ANTICAVITY- sodium fluoride rinse 
Wal-Mart

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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Anticavity Fluoride Rinse, Mint
213.002-213AE rev 2

TEP

Sealed with printed neckband for your protection

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

For this product

Keep out of reach of children

If more than used for rinsing is accidentall swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

inactive ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Adverse reactions

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716 Wal-Mart Stores, Inc.

Guarantee

Satisfaction guaranteed - Or we'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

Principal display panel

IMPORTANT: READ DIRECTIONS FOR PROPER USE

Exclusivo

Walmart

Anticavity

Fluoride Rinse

Mint

18 FL OZ (532 mL)

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
menthol (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/06/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/06/2001
Labeler - Wal-Mart (051957769)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(49035-213)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(49035-213)

Revised: 5/2023
Document Id: a31c8079-cd84-40dd-bcbd-779ef6c4ab19
Set id: cfb1b370-7172-4073-a5af-c272c6d38f46
Version: 12
Effective Time: 20230524
 
Wal-Mart