MOUTH RINSE- sodium fluoride mouthwash 
Topco associates LLC

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Top Care 163.005/163AF-AG

Claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

Sodium fluoride 0.0221% (0.01% 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 under 12 years of age and older:

•use twice daily after brushing your teeth with a toothpaste

•vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out

•do not swallow the rinse

•do not eat or drink anything for 30 minutes after rinsing

•supervise children as necessary until capable of using without supervision

•children under 12 years of age: consult a dentist or doctor

Other information

•store at controlled room temperature 20⁰ - 25⁰C (68⁰ - 77⁰ F)

•cold weather may temporarily cloud this product

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 manufactured or distributed by Johnson + Johnson Healthcare Products, distributed of Listerine Total Care Fresh Mint Anticavity Mouthwash.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

TOPCO VIJA0219   QUESTIONS? 1-888-423-0139 topcare@topco.com

This TOP CARE product is laboratory tested to guarantee its hightes quality. Your total satisfaction is guaranteed

DSP-TN 15000  DSP-MO-34  SDS-TN-15012

PRINCIPAL DISPLAY PANEL

COMPARE TO LISTERINE TOTAL CARE FRESH MINT ANTICAVITY MOUTHWASH

TopCare

everyday

FLUORIDE

Anticavity

Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

EUCALYPTUS MINT

6 Benefits

*This product is not intended to replace brushing or flossing

IMPORTANT: Read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ) 1 L

image description

MOUTH RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-001
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)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
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:36800-001-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02112/30/2010
Labeler - Topco associates LLC (006935977)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(36800-001)

Revised: 10/2023
Document Id: 7f74e3f1-8a42-433e-ab39-8a5dad9c833b
Set id: c640adc0-e178-4b6a-af44-07d2f7da81d3
Version: 12
Effective Time: 20231013
 
Topco associates LLC