FRAICHE KIDS BUBBLE GUM MOUTHWASH- sodium fluoride liquid 
True Marker Pharmaceuticals, Inc.

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Drug Facts

Active Ingredient 

SODIUM FLUORIDE  0.05%

(0.02% w/v fluoride ion)

Purpose

Dental Caries Preventive

Uses

 Aids in the prevention of dental cavities.

Warnings

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

Other information

Inactive Ingredients

Cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol.

This product does not contain ethyl alcohol.

Product label

image description

FRAICHE KIDS BUBBLE GUM MOUTHWASH 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-802
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
SORBITOL (UNII: 506T60A25R)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83592-802-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02107/01/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 6/2024
Document Id: 1be49c82-c9cd-58ba-e063-6394a90a0493
Set id: 2b466f85-da78-49a5-828e-a01bf8d01202
Version: 1
Effective Time: 20240627
 
True Marker Pharmaceuticals, Inc.