ANTICAVITY- sodium fluoride mouthwash 
Wal-Mart Stores, Inc

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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Equate 435.000/435AA

Active Ingredient

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

Purpose

Anticavity

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 accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

store at room temperature (59º-77ºF)

claims

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate and slightly or release air when opened.

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Vibrant Anticavity Mouthrinse

Satisfaction guaranteed- Or we'll replace it or give you your money back.  For questions or comments please call 1-888-287-1915

Adverse Reactions

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

principal display panel

equate

Compare to Literine

HeathyWhite

Anticavity Mouthwash

Glowing White

Anticavity

Mouthrinse

FRESH MINT

IMPORTANT: read directions for proper use.

32 FL OZ (946 mL)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-435
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)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
2NDC:49035-435-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2015
Labeler - Wal-Mart Stores, Inc (051957769)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(49035-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(49035-435)

Revised: 4/2022
Document Id: 8e5ba75b-b3df-4c37-b497-7effe721df59
Set id: 9e5806aa-b91a-4b8e-b869-6d6f306d10c9
Version: 12
Effective Time: 20220414
 
Wal-Mart Stores, Inc