GLOWING WHITE- sodium fluoride mouthwash 
Demoulas Super Markets, Inc

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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Market Basket 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 contact 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

store at room temperature (59º-77ºF)

Disclaimer

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

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

Adverse Reactions

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 East Street

Tewksbury, MA 01876

principal display panel

MORE FOR YOUR DOLLAR

MARKET BASKET

Compare to Listerine HealthyWhite Vibrant

Anticavity Mouthrinse

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

32 FL OZ (946 mL)

image description

GLOWING WHITE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-435
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, MONOHYDRATE (UNII: BWZ7K44R51)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53942-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/29/2015
Labeler - Demoulas Super Markets, Inc (007869647)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(53942-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(53942-435)

Revised: 4/2022
Document Id: 1b994030-0efc-4138-a17c-aabbd22cecc8
Set id: 32faf47d-b64f-4454-9f14-51503504c6b5
Version: 11
Effective Time: 20220421
 
Demoulas Super Markets, Inc