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  412.000  412AA

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, sorbitol, hydrogen peroxide, PEG-40 hydrigebated castor oil, poloxamer 407, sodium saccharin, menthol, flavor, phosphoric acid, disodium phosphate, sucralose

Other information

store at room temperature (59º-77ºF)

Questions?

Call 1-888-287-1915

other information

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

Satisfaction guarannteed- Or we'll replace it or give you your money back.

For questions or comments please call 1-888-287-1915

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, owner of the registered trademark Listerine Healthy White Restoring Anticavity Mouthrinse

Adverse reactions section

DISTRIBUTED BY: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

principal display panel

equate

Compare to Listerine Healthy White Resotring Anticavity

Whiten & Restore

Anticavity

Mouthrinse

Minty Fresh

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:49035-942
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)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-942-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/13/2017
2NDC:49035-942-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/13/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/13/2017
Labeler - Wal-Mart Stores, Inc (051957769)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(49035-942)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(49035-942)

Revised: 5/2022
Document Id: 6d0660c2-e90e-4074-a5f7-2cf95dd30d96
Set id: aa13fa0d-dc10-44bf-be9a-03609703b6ed
Version: 11
Effective Time: 20220505
 
Wal-Mart Stores, Inc