FDA.reportPublic FDA data

Fraiche Kids Paste, Bubble Gum Flavor

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 20:59:47

Label at a glance#

ProductFraiche Kids Paste, Bubble Gum Flavor
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

 Aids in the prevention of dental cavities.

Dosage and administration

For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results, brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use. For children under 2 years of age, consult a dentist or physician.

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

0.24% w/w Sodium Fluoride

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Uses

INDICATIONS & USAGE SECTION

 Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If more than the recommended amount of the paste used for brushing is
accidentally swallowed, get medical help or contact the Poison Control Center right away. In case of an allergic reaction, stop use, rinse mouth with water and seek medical advice.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 years of age or older, apply a small peasized amount of FRAICHE Kids dental gel to your toothbrush. For best results,

brush for 2 minutes, expectorate and avoid eating or drinking for 30 minutes after brushing. Use twice daily. Replace cap after use.

For children under 2 years of age, consult a dentist or physician.

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

Pure Water, Glycerol, Sorbitol, CMC-NA, Propylene Glycol, Silicon Dioxide, Titanium Dioxide, Xylitol, Phosphoric Acid, Flavoring, Sodium
Saccharin, Ethyl P-hydroxybenzoate, Propyl P-hydroxybenzoate, Butyl P-hydroxybenzoate, Sodium-N-lauroyl Sarcosinate.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83592-80383592-803-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XYLITOLVCQ006KQ1EIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ETHYLPARABEN POTASSIUM528JBB2994IACT
BUTYL SALICYLATEQPR9LM8VZOIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
PROPYLPARABENZ8IX2SC1OHIACT
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
27eb6e41-bce4-27f3-e063-6394a90a5ef47a592ac5-91c1-4de6-85ea-ea2696ad29282024-11-27WarningsExact identifier
spl set id: 7a592ac5-91c1-4de6-85ea-ea2696ad2928

Reported adverse events (FAERS/openFDA)#

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