FRAICHE 5000 KIDS DENTAL BUBBLE GUM

Manufacturer
True Marker Pharmaceuticals, Inc.
Effective date
2024-10-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:26

Label at a glance#

ProductFRAICHE 5000 KIDS DENTAL BUBBLE GUM
Active ingredientSODIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE
Label structure10 sections

Indications and uses

This 1.1% neutral sodium fluoride and 3% calcium hydroxyapatite dental gel is intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Dosage and administration

Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and children 12 years of age and older. Twist off cap and remove foil seal. Apply at least a 1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth.

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

1.1% sodium fluoride

3% calcium hydroxyapatite

Purpose

OTC - PURPOSE SECTION

Dental gel

Uses

INDICATIONS & USAGE SECTION

This 1.1% neutral sodium fluoride and 3% calcium hydroxyapatite dental gel is intended to aid in the prevention of dental
decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Warnings

WARNINGS SECTION

Do not swallow.Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away.Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Contraindications: Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 12 unless directed by a dentist or physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6 Years of Age: Consult a dentist or physician.

Directions

DOSAGE & ADMINISTRATION SECTION

Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and children 12 years of age and older. Twist off cap and remove foil seal. Apply at least a 1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth.

Other information

SPL UNCLASSIFIED SECTION

To report suspected adverse reactions, contact True Marker Pharmaceuticals at (877) 887-9879 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sorbitol, Xanthan Gum, Flavor, Yucca Shidigera Root Extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root Extract, Dioscorea Villosa Root Extract, Tocopheryl Acetate,Cocamidopropyl Betaine, Benzyl Alcohol.

Questions or Comments?

SPL UNCLASSIFIED SECTION

To report suspected adverse reactions, contact True Marker Pharmaceuticals at (877) 887-9879 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

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 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83592-81783592-817-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
27eb3a1d-a883-af38-e063-6394a90abda0533c9c1b-22db-4aca-9237-235ac21676fa2024-11-27WarningsExact identifier
spl set id: 533c9c1b-22db-4aca-9237-235ac21676fa

Reported adverse events (FAERS/openFDA)#

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