ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash 
Consumer Product Partners, LLC

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Swan 004 004.002/004AE
Anticavity Fluoride Rinse

Claims

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

Active ingredient

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

Purpose

Anticavity rinse

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

Directions

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

Other information

Disclaimer

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

Adverse reaction

Distributed by: Vi-Jon, LLC, One Swan Drive, Smyrna, TN 37167

Principal display panel

Sealed With Printed Neckband For Your Protection

SWAN

KIDS ANTICAVITY ALCOHOL FREE FLUORIDE RINSE

bubble gum FLAVOR

Strong Cavity Protection

Compare to the active ingredient of Act ®Bubblegum Blowout Anticavity Fluoride Rinse*

IMPORTANT:READ DIRECTIONS FOR PROPER USE

18 FL OZ (532 mL)

image description

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-004
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 (UNII: 25IH6R4SGF)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DISODIUM DIHYDROGEN HYPOPHOSPHATE (UNII: MR6TW8IQ9X)  
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:11344-004-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/29/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02102/29/2024
Labeler - Consumer Product Partners, LLC (119091520)
Registrant - Consumer Product Partners, LLC (119091520)
Establishment
NameAddressID/FEIBusiness Operations
Consumer Product Partners, LLC119091514manufacture(11344-004)

Revised: 2/2024
Document Id: 128c0196-08d6-31cb-e063-6294a90aed5b
Set id: c71d4064-f938-477b-9346-eb38be65390d
Version: 2
Effective Time: 20240229
 
Consumer Product Partners, LLC