ANTICAVITY RINSE- 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.

----------

Anticavity Fluoride Rinse, Bubble Gum
004.002/004AE

Active ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion

Purpose

Anticavity rinse

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, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Bubblegum Blowout Anticavity Kids Fluoride Rinse.

Distributed by:

Rite Aid 30 Hunter Lane,

Camp Hill, PA 170111

www.riteaid.com

SATISFACTION GUARANTEE

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

Principal Panel Display

Sealed with printed neckband for your protection

Compare to Act Bubblegum Blowout Anticavity Kids Fluoride Rinse*

Free From

Alcohol Free

Kids Anticavity 

Fluoride Rinse

Bubble Gum Flavor

strong cavity protection

helps strengthen teeth & prevent cavities

fresh & clean

Important: read directions for proper use.

18 FL OZ (532 mL)

image description

ANTICAVITY RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-4004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
poloxamer 407 (UNII: TUF2IVW3M2)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
propylene glycol (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate (UNII: SE337SVY37)  
saccharin (UNII: FST467XS7D)  
sorbitol (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-4004-4532 mL in 1 PACKAGE; Type 0: Not a Combination Product12/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/05/2022
Labeler - Rite Aid (014578892)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(11822-4004)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(11822-4004)

Revised: 12/2022
Document Id: cbb38220-c609-45c9-9a54-3ff732484d77
Set id: c1a22692-b955-498a-a7c1-1cd7bfd54bda
Version: 1
Effective Time: 20221205
 
Rite Aid