ANTICAVITY FLUORIDE RINSE- 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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Anticavity Fluoride Rinse, Mint
213.002/213AE rev 2

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

Sodium Fluoride 0.05% (0.02% 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, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Questions?

Call 1-888-423-0139

Adverse reactions

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash

DISTRIBUTED BY: TOCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

(C) TOPCO VIJ717  QUESTIONS? 1-888-423-0139

topcare@topcare.com  www.topcarebrand.com

QUALITY GUARANTEED

This Top Care product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Principal display panel

COMPARE TO ACT*

TopCare

everyday

ALCOHOL FREE

Anticabity

Fluoride Mouth Rinse

MINT

IMPORTANT: Read direction for proper use.

ADA Accepted 

American Dental Association

18 FL OZ (1 PT 2 FL OZ) 532 mL

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-213
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)  
sorbitol (UNII: 506T60A25R)  
MENTHOL (UNII: L7T10EIP3A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
poloxamer 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/20/2003
Labeler - Topco Associates, LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-213)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-213)

Revised: 5/2023
Document Id: e82298e5-9144-4d3d-bf4d-c943c14f265a
Set id: f760f8f8-0c74-4a6e-b5c9-cc82b8758a45
Version: 11
Effective Time: 20230524
 
Topco Associates, LLC