FDA.reportPublic FDA data

Fraiche Kids Bubble Gum Mouthwash

Manufacturer
True Marker Pharmaceuticals, Inc.
Effective date
2024-06-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:46

Label at a glance#

ProductFraiche Kids Bubble Gum Mouthwash
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

 Aids in the prevention of dental cavities.

Dosage and administration

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 unti...

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE  0.05%

(0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Dental Caries Preventive

Uses

INDICATIONS & USAGE SECTION

 Aids in the prevention of dental cavities.

SPL UNCLASSIFIED SECTION

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83592-80283592-802-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
SORBITOL506T60A25RIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27eb515c-d87b-f1c2-e063-6394a90a2e2a2b466f85-da78-49a5-828e-a01bf8d012022024-11-27WarningsExact identifier
spl set id: 2b466f85-da78-49a5-828e-a01bf8d01202

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.