ANTICAVITY- sodium fluoride mouthwash 
Meijer Distribution, Inc

----------

Restoring Anticavity Fluoride Mouthwash
581.000/581AA-AC

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

Sodium fluoride 0.02% (0.009% 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 (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Questions?

Call 1-888-593-0593

Disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act® Restoring Anticavity Fluoride Mouthwash Cool Mint.

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

The Meijer Family

WWW.MEIJER.COM/sATISFACTION

Principal display panel

NDC 41250-581-86

meijer

Compare to Act® Restoring Anticavity Fluoride Mouthwash Active Ingredient*

RESTORING ANTICAVITY

Fluoride Rinse

Sodium Fluoride And Acidulated Phosphate Topical Solution

RESTORES ENAMEL

Refreshing Mint

Helps strengthen teeth

Helps remineralize soft spots

Freshens breath

IMPORTANT: Read directions for proper use

33.8 FL OZ (1L) 1.05 QT

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-581
Route of Administrationoral
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02110/18/2016
Labeler - Meijer Distribution, Inc (006959555)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41250-581)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41250-581)

Revised: 11/2023
Document Id: b2b71319-861a-4f76-9b9b-3e8946e8e733
Set id: acff939e-e98c-4d89-a0c4-0254dc74e672
Version: 9
Effective Time: 20231106
 
Meijer Distribution, Inc