ANTICAVITY- sodium fluoride mouthwash 
Rite Aid

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:

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

Disclaimer

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

Claims

Gluten Free

Sugar Free

Paraben Free

Adverse Reaction

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMPHILL, PA 17011

www.riteaid.com

SATISFACTION GUARANTEE

If you're not satisfied, we'll happily refund your money.

principal display panel

Sealed with printed neckband for your protection

IMPORTANT: read directions for proper use.

Compare to Act Restoring Anticavity Fluoride Mouthwash*

GLUTEN FREE

SUGAR FREE

RESTORING 

ANTICAVITY FLUORIDE 

MOUTHWASH

REFRESHING MINT

restores enamel

helps avoid tooth decay

helps remineralize soft spots

freshens breath

33.8 FL OZ (1 L)

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6877
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:11822-6877-81000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/04/2017
Labeler - Rite Aid (014578892)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(11822-6877)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(11822-6877)

Revised: 7/2023
Document Id: 72625e87-f40c-482e-b2b2-9c9d580dee5a
Set id: 87356f76-4f5c-4834-9ad3-2e49bc227129
Version: 9
Effective Time: 20230727
 
Rite Aid