ANTICAVITY- sodium fluoride rinse 
Shopko Stores Operating Co., 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.

----------

Anticavity Fluoride Rinse, Mint
213.002/213AE rev 2

Active Ingredients

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, see 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

Disclaimer

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

Adverse reactions

Manufactured by Vi-Jon, Inc.,

One Swan Drive, Smyrna, TN 37167

for Shopko Stores Operating Co., LLC

www.shopko.com

for consumer questions

call 1-888-593-0593

SHOPKO

Satisfaction

Guaranteed by refund or exchange

Principal display panel

SHOPKO

COMPARE TO THE ACTIVE INGREDIENT OF ACT

Anticavity

Fluoride

Rinse

Mint Flavor

Strong cavity protection

Helps strengthen teeth

Helps prevent cavities

Freshens breath

Alcohol Free

IMPORTANT: read directions for proper use

18 FL OZ (532 mL)

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-213
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 (UNII: 25IH6R4SGF)  
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:37012-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/02/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/02/2011
Labeler - Shopko Stores Operating Co., LLC (023252638)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37012-213)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37012-213)

Revised: 5/2023
Document Id: 8a4d137e-efbb-42c3-97c6-d173f2cf0aa5
Set id: d20808c0-ad6c-4b99-badf-3d7b1d14a874
Version: 12
Effective Time: 20230524
 
Shopko Stores Operating Co., LLC