ANTICAVITY- sodium fluoride mouthwash 
Walgreens

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-AC

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredients

Sodium fluoride 0.02% (0.009% w/v fluoride ion)

Purpose

Anticavity

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, 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 1-800-925-4733

Disclaimer

Waalgreens Pharmacist Recommended

Walgreens Pharmacist Survey

††This product is not manufactured or distributed by Chattem Inc., distributor of ACT® Restoring Anticavity Fluoride Mouthwash.

Adverse Reactions

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

WALGREENS

100% SATISFACTION

GUARANTEED

walgreens.com 2018 Walgreen Co.

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Walgreens

Compare to Act® Restoring Anticavity Fluoride Mouthwash active ingredient††

NEW LOOK SAME GREAT QUALITY

Mouth Rinse

ANICAVITY

Mouth Rinse

SODIUM FLUORIDE

33.8 FL OZ (1 L)

REFRESHING MINT

IMPORTANT: Read directions for proper use.

image description

ANTICAVITY 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0581
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:0363-0581-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/03/2017
Labeler - Walgreens (008965063)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0363-0581)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0363-0581)

Revised: 7/2023
Document Id: a2c1c004-a355-4594-97bb-f7de3f9af157
Set id: 9aefb703-3a1b-485d-9507-18fd5cf7a03a
Version: 12
Effective Time: 20230727
 
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