ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Midwood Brands, Inc

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Anticavity Fluoride Rinse (Mint)
163.005/163AF-AG

Active ingredient

Sodium fluoride 0.02% (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:

Other information

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

Disclaimer

This product is not manufacturd or distributed by Johnson & Johnson Corporation, distributerof Listerine® Total Care Fresh Mint Anticavity Mouthwash.

Adverse Reaction

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

MADE IN THE US WITH US AND FOREIGN COMPONENTS.

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or Exchange.

DSP-TN-21091

DSP-MO-20087

principal display panel

Sealed with printed neckband for your protection.

Do not use if band around cap is broken or missing.

FAMILY WELLNESS™

COMPARE TO LISTERINE® TOTAL CARE FRECH MINT ANTICAVITY MOUTHWASH

MINT

ANTICAVITY FLUORIDE RINSE

Sodium Fluoride and Acidulated Phosphate Topical Solution

MINT FLAVOR ANTICAVITY FLUORIDE MOUTHWASH

1 L (1.05 QT) 33.8 FL OZ

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.1 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:55319-163-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02112/14/2011
Labeler - Midwood Brands, Inc (024472631)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(55319-163)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(55319-163)

Revised: 10/2023
Document Id: 9d84e7ee-eefa-405e-8f92-283931d415fc
Set id: 32ebc633-5338-4d5a-b075-f10b24761248
Version: 12
Effective Time: 20231030
 
Midwood Brands, Inc