ANTICAVITY- sodium fluoride mouthwash 
TOPCO ASSOCIATES 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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Top Care 435.000-435AA

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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:

Inactive ingredients

water, alcohol (8%), hydrogen peroxide, poloxamer 407, sodium saccharin, sucralose, menthol, phosphoric acid, disodium phosphate, flavor

Other information

other information

Contains peroxide which releases oxygen while whitening.  This may cause the bottle to inflate slightly or release air when opened.

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Healthy White Vibrant Anticavity Mouthrinse

Adverse reactions

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com    www.topcarebrand.com

principal display panel

COMPARE TO LISTERINE HEALTHYWHITE

Top Care

everyday

FLUORIDE

Whitening

Antivavity Mouthwash

SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION

FRESH MINT

IMPORTANT: Read direction for proper use.

16 FL OZ (1 PT) 473 mL

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-803
Route of Administrationoral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MENTHOL (UNII: L7T10EIP3A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-803-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
2NDC:36800-803-43474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/15/2015
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-803)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-803)

Revised: 4/2022
Document Id: 70f4a9d3-afa4-43fd-a54d-af63dace630c
Set id: c337c982-bd18-4a1a-851a-fca1551a242e
Version: 10
Effective Time: 20220427
 
TOPCO ASSOCIATES LLC