ANTICAVITY- sodium fluoride liquid 
ShopKo

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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Shopko 435.000  435AA

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 contct a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine HealthyWhite Anticavity Mouthrinse

Other safety information

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

Adverse Reactions

Manufactured by:

Vi-Jon, LLC 1 Swan Drive

Smyrna, TN 37167

Shopko Store Operating Co, LLC

www. shopko.com

For consumer questions

call 1-888-593-0593

Satisfaction 

SHOPKO

Guaranteed

principal display panel

ShopKo

NDC 37012-435-43

COMPARE TO THE

INGREDIENTS OF LISTERINE

Glowing

White

Anticavity Mouthrinse

Fresh Mint

Begins working on contact

5 days to whiter teeth

Helps strengthen teeth

Kills germs that cause bad breath

Sealed With Printed Neckband For Your Protection

IMPORTANT: read directions for proper use.

16 fl oz (474 mL)

image description

ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-435
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)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-435-43474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2015
Labeler - ShopKo (023252638)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37012-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37012-435)

Revised: 4/2022
Document Id: a30f768c-dd7a-44f9-ad95-0dce7888d94f
Set id: 231a9436-9d68-413c-b2a1-775bdede9e20
Version: 10
Effective Time: 20220427
 
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