ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Retail Business Services, LLC

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

Active Ingredient

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

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredient

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

Disclaimer

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

DISTRIBUTED BY: FOODHOLD, U.S.A., LLC

Landover, MD 20785   1-877-846-9949

(c) 2018 S7S Brands, LLC

Quality guaranteed or your money back.

Principal Panel Display

CAREONE

Compare to Act Anticavity Fluoride Rinse*

ANTICAVITY

FLUORIDE RINSE

MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use

18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-213
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 MONOHYDRATE (UNII: PKV6BFV915)  
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:72476-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/24/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/24/2010
Labeler - Retail Business Services, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-213)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-213)

Revised: 5/2023
Document Id: c8d473cc-ea7c-4a12-b760-a23a94755499
Set id: d1c878a9-2151-4986-be09-cbab658cdd31
Version: 15
Effective Time: 20230524
 
Retail Business Services, LLC