ANTICAVITY- sodium fluoride mouthwash 
DZA Brands

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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Healthy Accents 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

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: DZA BRANDSA, LLC

2110 Excutive Drive, Salisbury, NC 28147

For product questions or comcerns, contact us at 1-866-322-2439

Please include UPC number and code from package

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

healthy

accents

glowing white

anticavity

mouth rinse

fresh mint

compare to Listerine Healthy White

Vibrant Anticavity Mouthrinse

32 FL OZ (1 QT) 946 mL

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-435
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:55316-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/11/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/11/2015
Labeler - DZA Brands (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-435)

Revised: 4/2022
Document Id: 1a182dfa-cdce-48bb-8c97-99a916fede6d
Set id: 5fce4f46-bbfb-4c2d-87c3-74eb33a35c42
Version: 11
Effective Time: 20220420
 
DZA Brands