ANTICAVITY- sodium fluoride rinse 
United Natural Foods, Inc. dba UNFI

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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Anticavity Fluoride Rinse
971.001-971AB

Active Ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warning

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 immediately

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

Sealed With Printed Neckband For Your Portection

Do Not Use If Band Around Cap Is Broken or Missing.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributer or Listerine Total Care Zero Alcohol Anticavity Fresh Mist Mouthwash.

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA

Principal panel display

compare to Listerine Total Care Zero Alcohol Mouthwash active ingredient*

EQUALINE

Fluoride Anti-Cavity

Mouthwash

Sodium Fluoride and Acidulated

Phosphate Topical Solution

IMPORTANT: read directions for proper use.

FRESH MINT

1 L (33.8 FL OZ)

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-971
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 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)  
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:41163-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2021
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41163-971)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41163-971)

Revised: 5/2023
Document Id: 9e9c83ae-3158-4384-a6e2-30bafec7442e
Set id: 9d055fed-26d8-4827-a4cc-8c314514a6c3
Version: 2
Effective Time: 20230510
 
United Natural Foods, Inc. dba UNFI