ORAL ANTIVAVITY- sodium fluoride mouthwash 
Topco

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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Whitening Anticavity Rinse
576.001/576AC

claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECION

TopCare

everyday

active ingredient

Sodium fluoride 0.0219% (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 6 years of age and older:

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions?

Call 1-888-423-0139

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLATE, IL 60007

©TOPCO VIJA0122  QUESTIONS? 1-888-423-0139

This rinse may cause temporary staining to the surface of teeth. This is not harmful, add adequate brushing may prevent its occurence

This product is not manufactured or distributed by Procter & Gamble, distributof of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

This product is not intended to replace brushing or flossing

Principal display panel

COMPARE TO CREST PRO-HEALTH ADVANCED ANTICAVITY FLUORIDE MOUTHWASH

TopCare

everyday

ALOHOL FREE

Fluoride

Anticavity Mouthwash

REFRESHING MINT

IMPORTANT: Read directions for proper use.

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

image description

ORAL ANTIVAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-576
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION10.41 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-576-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/04/2022
Labeler - Topco (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(76162-576)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(76162-576)

Revised: 4/2022
Document Id: e02c42a7-295f-4424-9a64-191978bb865f
Set id: 84b30711-a7e5-4189-895a-a7989f05591c
Version: 2
Effective Time: 20220407
 
Topco