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.

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Anticavity Fluoride Rinse, Bubble Gum
004.001/004E

Active ingredient

Sodium fluoride 0.055% (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 accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Sealed with printed neckband for your protection.

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

Manufactured by Vi-Jon, LLC.,

One Swan Dr., Smyrna, TN 37167

for ShopKo Stores Operating Co., LLC

www.shopko.com

For consumer questions call 1-888-593-05936

ShopKo Satisfaction Guaranteed By Refund Or Exchange

principal display panel

ShopKo

Compare to the Active Ingredient of Act*

Kids Anticavity Fluoride Rinse

Bubble Gum Flavor

Strong cavity protection

Helps strengthen teeth mm1.jpg

Helps prevent cavities

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:37012-004
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/15/2011
Labeler - Shopko Stores Operating Co.LLC (023252638)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37012-004)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37012-004)

Revised: 1/2023
Document Id: 80820bf9-3c72-48c0-9128-65ad2041c9be
Set id: 22130752-2b0b-41a6-abf1-6b7132789f96
Version: 13
Effective Time: 20230111
 
Shopko Stores Operating Co.LLC