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 Mouthrinse
201.000/201AA

Active ingredient

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

Purpose

Anticavity rinse

Use

aids in the prevention of dental cavities

Warnings

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

Adults and children 6 years and older:

Children under 6 years of age: consult a dentist or doctor

Other information

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 80, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5

Sealed with printed neckband for your protection

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

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Kids Anticavity Fluoride Rinse Wild Watermelon.

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716 Wal-Mart Stores, Inc.

201.000/201AA

principal display panel

NDC 79903-033-44

Equate

Compare to Act Kids Anticavity Fluoride Rinse Wild Watermelon*

Kids Anticavity Fluoride Rinse

Watermelon Flavor

IMPORTANT: Read directions for proper use

18 FL OZ (1 PT 2 FL OZ) 532 mL

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-033
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79903-033-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/19/2020
Labeler - Wal-Mart (051957769)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(79903-033)

Revised: 12/2022
Document Id: 629ee11a-efc0-4eb6-b826-bb6a7f1352e9
Set id: 61669087-0af6-4192-b514-afcfe7d8ba98
Version: 2
Effective Time: 20221206
 
Wal-Mart