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 Anticavity Fluoride Mouthrinse 163.005/163AF-AG

Active ingredient

Sodium fluoride 0.02% w/v (0.01%w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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 12 years of age and older:

Inactive ingredients

water, alcohol (21.6 %v/v), sorbitol, poloxamer 407, eucalyptol, flavor, methyl salicylate, menthol, phosphoric acid, sodium saccharin, thymol, disodium phosphate, sucralose, red 40, blue 1

Other information

Sealed With Printed Neckband For Your Protection

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Total Care anticavity Mouthwash.

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

2013 S&S BRANDS, LLC

Quality guaranteed or your money back

Principal display panel

Compare to the Active Ingredient of Listerine Total Care Fresh Mint Anticavity Mouthwash*

CARE ONE

ANTICAVITY MOUTH WASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION

MINT FLAVOR

IMPORTANT: Read directions for proper use

33.8 FL OZ (1 L)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
THYMOL (UNII: 3J50XA376E)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-005-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/12/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/12/2005
Labeler - RETAIL BUSINESS SERVICES , LLC (967989935)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(72476-005)

Revised: 9/2023
Document Id: 13753836-1022-428b-9bfd-b979f180951b
Set id: 35385ada-bd8d-4d38-9587-0256885f749f
Version: 10
Effective Time: 20230919
 
RETAIL BUSINESS SERVICES , LLC