ANTICAVITY RINSE- sodium fluoride mouthwash 
Retail Business Services, LLC

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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Anticavity Fluoride Rinse, Bubble Gum
004.002/004AE

Active ingredient

Sodium Fluoride 0.05% (0.2% w/v fluoride ion)        

Purpose

Anticavity Rinse

Use

aids in the prevention of dental cavities

Warnings

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

store at room temperature

Inactive ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 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 Kids Anticavity Fluoride Rinse Bubblegum Blowout

Distributed by Foodhold, U.S.A, LLC

4201 Walden Avenue

Landover, MD 20785 1-877-846-9949

(c)2018 S&S Brands, Inc.

Quality Guaaranteed or your money back

principal display panel

CAREONE

Compare to Act Kids Anticavity Fluride Rinse*

CHILDREN'S

ANTICAVITY

FLUORIDE RINSE

Stong Cavity

Protection

Alcohol Free

BUBBLE GUM FLAVOR

Sealed with printed neckband for your protection

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:72476-204
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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 SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-204-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2010
2NDC:72476-204-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/10/2010
Labeler - Retail Business Services, LLC (967989935)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(72476-204)

Revised: 1/2023
Document Id: 0c7de326-a1ea-43d7-86ee-60c252f6d0b4
Set id: 77c066cf-f064-45d3-9732-4433165ba9ef
Version: 4
Effective Time: 20230106
 
Retail Business Services, LLC