FRAICHE 5000 PREVI

Manufacturer
True Marker Pharmaceuticals, Inc.
Effective date
2025-10-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:41:25

Label at a glance#

ProductFRAICHE 5000 PREVI
Active ingredientSODIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE
Label structure12 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 6 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. Children under...

Storage and handling

4.3 ounces (122g) in plastic tube. Store at room temperature 59-86° F (15-30 - °C)

Label contents#

Full prescribing information#

Active Ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.1% and Calcium Hydroxyapatite 3%

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 no 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.

Adverse reactions

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.

Children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 6 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.
Children under 6 years of age: Consult a dentist or physician.

Dosage form and Strengths

SPL UNCLASSIFIED SECTION

Dental gel containing 1.1 % sodium fluoride and 3% calcium hydroxyapatite.

Contraindications

SPL UNCLASSIFIED SECTION

Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician.

Description

SPL UNCLASSIFIED SECTION

Fraiche 5000 Previ dental gel is a flavored, pH neutral 1.1 % sodium fluoride and 3% calcium hydroxyapatite that aids in the prevention of dental decay and helps to treat sensitive teeth.

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.

How supplied/storage

SPL UNCLASSIFIED SECTION

4.3 ounces (122g) in plastic tube. Store at room temperature 59-86° F
(15-30 - °C)

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83592-815-04GM - Gram83592-8150f8e7c34-9188-4dda-9276-ce3c4c780af612024-05-16

Products#

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DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83592-81583592-815-04

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-03-14full-release2026-05-31 21:01:01

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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
47e4f693-fde0-a626-e063-6394a90a445ae6a0ed29-a819-42e7-947f-b49eff0690632026-01-08WarningsExact identifier
spl set id: e6a0ed29-a819-42e7-947f-b49eff069063

Reported adverse events (FAERS/openFDA)#

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