Fraiche Kids Bubble Gum Mouthwash by True Marker Pharmaceuticals, Inc. Drug Facts

Fraiche Kids Bubble Gum Mouthwash by

Drug Labeling and Warnings

Fraiche Kids Bubble Gum Mouthwash by is a Otc medication manufactured, distributed, or labeled by True Marker Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

----------

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

• Use once a day after brushing your teeth with a toothpaste
• Remove cap
• Hold bottle upright and squeeze. Fill to FILL LINE (10mL)
• Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Do not eat or drink for 30 minutes after rinsing
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
• Supervise children as necessary until capable of using without supervision
• Children under 6 years of age: consult a dentist or doctor

Other information

• Store at controlled room temperature, 68-77°F (20-25°C).
• Do not use if safety seal is broke or missing.

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

FRAICHE KIDS BUBBLE GUM MOUTHWASH 
sodium fluoride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83592-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83592-802-10	300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2024	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2024	12/01/2024

Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Establishment
Name	Address	ID/FEI	Business Operations
Samson Pharmaceuticals, Inc		088169581	manufacture(83592-802)

Revised: 11/2024

Document Id: 27eb515c-d87b-f1c2-e063-6394a90a2e2a

34390-5

Set id: 2b466f85-da78-49a5-828e-a01bf8d01202

Version: 2

Effective Time: 20241127