ANTICAVITY- sodium fluoride mouthwash 
Meijer Distribution, Inc

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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Restoring Anticavity Fluoride Mouthwash
581.000/581AA-AB

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:

  • use twice a day 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 for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

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

Sealed With Printed Neckband For Your Protection

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

principal display panel

NDC 41250-581-86

Compare to Act Restoring Anticavity Fluoride Mouthwash

meijer

Refreshing Mint Restoring Anticavity Fluoride Rinse

Sodium Fluoride And Acidulated Phosphate Topical Solution

Anticavity Mouthwash

Helps Strengthen teeth

Restores enamel

Helps remineralize soft spots

IMPORTANT: Read directions for proper use

33.8 FL OZ (1 L)

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) FLUORIDE ION0.2 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 finalpart35510/18/2016
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: 12/2022
Document Id: 4821468e-6030-4dbc-bddf-be554ac54f7c
Set id: acff939e-e98c-4d89-a0c4-0254dc74e672
Version: 7
Effective Time: 20221212
 
Meijer Distribution, Inc