ANTICAVITY- sodium fluoride rinse 
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.

----------

Burn-Free Fluoride Anti-Cavity Mouthwash
971.001/971AB

Sealed With Printed Neckband for Your Protection

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:

Children under 6 years of age: consult a dentist or doctor

Other information

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash

DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions and concerns,

contact us at 1-833-992-3872

Quality guaranteed or your money back.

Principal Panel Display

CAREONE

Compare to Listerine Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*

BURN FREE FLUORIDE

ANTI-CAVITY MOTHWASH

SODIUM FLUORIDE AND ACIDULATED

PHOSPHATE TOPICAL SOLUTION

HELPS STRENGTHEN TEETH TO FIGHT CAVITIES

HELPS RESTORE ENAMEL

FRESH MINT FLAVOR

IMPORTANT: read directions for proper use.

NET 33.8 FL OZ (1.05 QT) 1L

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-971
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)  
sorbitol (UNII: 506T60A25R)  
propylene glycol (UNII: 6DC9Q167V3)  
poloxamer 407 (UNII: TUF2IVW3M2)  
sodium lauryl sulfate (UNII: 368GB5141J)  
sodium benzoate (UNII: OJ245FE5EU)  
phosphoric acid (UNII: E4GA8884NN)  
eucalyptol (UNII: RV6J6604TK)  
methyl salicylate (UNII: LAV5U5022Y)  
thymol (UNII: 3J50XA376E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
menthol (UNII: L7T10EIP3A)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
sucralose (UNII: 96K6UQ3ZD4)  
SPEARMINT OIL (UNII: C3M81465G5)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-971-861000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/08/2022
Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-971)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-971)

Revised: 4/2023
Document Id: 6779331a-c2f3-4883-9a66-1e0baa3abd1b
Set id: 3954edfd-f7f1-4218-9ee2-23f5b3661b4e
Version: 2
Effective Time: 20230421
 
RETAIL BUSINESS SERVICES, LLC