ANTICAVITY- sodium fluoride mouthwash 
RETAIL BUSINESS SERVICES, 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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Care  One 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 slightl or release air when opened.

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

S & S brands, LLC

1-887846-8484

Quality Guaranteed or your money back

principal display panel

CAREONE

Compare to Listerine HealthyWhite Vibrant Anticavity Mouthrinse

ADVANCED

WHITENING

ANTICAVIRY MOUTHRINSE

5 DAYS TO WHITER TEETH

BEGINS WORKING ON CONTACT

SAFELY WHITENS TEETH

KILLS GERMS THAT CAUSE BAD BREATH

FRESH MINT FLAVOR

Sealed With Printed Neckband For Your Protection

IMPORTANT: Read directions for proper use.

16 FL OZ (1 PT) 473 mL

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-435
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:72476-435-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2015
2NDC:72476-435-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2015
Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-435)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-435)

Revised: 4/2022
Document Id: 69e671a5-1136-44f7-acaf-79ccc718cb2e
Set id: cf0c8b48-0d1c-406a-a67d-7d16187d38d8
Version: 12
Effective Time: 20220413
 
RETAIL BUSINESS SERVICES, LLC