ANTICAVITY- sodium fluoride rinse 
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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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Burn-Free Fluoride Anti-Cavity Mouthwash
971.001/971AB

Active Ingredients

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

Purpose

Anticavity rinse

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 right away

Directions

Adults and children 6 years of age and older:

Other information

Inactive ingredients

water, sorbitol, propylene glycol, flavor, sodium lauryl sulfate, poloxamer 407, sodium benzoate, phosphoric acid, sodium saccharin, disodium phosphate, sucralose, red 40, blue 1

Disclaimer

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

This product is not intended to replace brushing or flossing.

SEALED WITH PRINTD NECKBND FOR YOUR PROTCTION

PUBLIX GUARNTEE: COMPLETE SATIFACTION OR YOUR MONEY BACK

Adverse reactions section

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811 publix.com

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ANTICAVITY

alcoholfree

MOUTHWASH

Sodium Fluoride & Acidulated

Phosphate Topical Solution

Fress mint flavor

Compare to Listerine Total Care Zero Anticavity Mouthwash

Cleans the entire mouth

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1.05 QT) 1 L

image description

ANTICAVITY 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-971
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
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:56062-971-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/08/2019
Labeler - publix (006922009)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(56062-971)

Revised: 12/2022
Document Id: 9f24528a-d326-4596-868c-6998e0338a9a
Set id: f0e84078-499f-4a5a-bcd2-23f57805de86
Version: 4
Effective Time: 20221214
 
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