Indications and uses
This 1.1% neutral sodium fluoride and 4.5% potassium nitrate 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.
FRAICHE 5000 SENSITIVE
- Manufacturer
- True Marker Pharmaceuticals, Inc.
- Effective date
- 2024-04-10
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:00:36
Label at a glance#
ProductFRAICHE 5000 SENSITIVE
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure12 sections
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)
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
Active Ingredient (s)
Sodium Fluoride 1.1% and Potassium Nitrate 4.5%.
Uses
This 1.1% neutral sodium fluoride and 4.5% potassium nitrate 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
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
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
Consult a dentist or physician.
Directions
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
Dental gel containing 1.1% sodium fluoride and 4.5% potassium nitrate.
Contraindications
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
Fraiche 5000 Previ dental gel is a flavored, pH neutral 1.1 % sodium fluoride and 3% calcium hydroxy apatite that aids in the prevention of dental decay and helps to treat sensitive teeth.
Inactive Ingredients
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
4.3 ounces (122g) in plastic tube. Store at room temperature 59-86° F
(15-30 - °C)
Product label
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83592-816-04 | GM - Gram | 83592-816 | aee4da4b-0a1e-4df5-a3cb-b534bc2a5f7e | 1 | 2024-05-16 |
Products#
Every source-derived product name is available through these pages.
- FRAICHE 5000 SENSITIVE
- SODIUM FLUORIDE,POTASSIUM NITRATE
- WATER
- GLYCERIN
- HYDRATED SILICA
- CALCIUM CARBONATE
- XYLITOL
- SORBITOL
- XANTHAN GUM
- YUCCA SCHIDIGERA WHOLE
- QUILLAJA SAPONARIA BARK
- SMILAX ARISTOLOCHIIFOLIA ROOT
- DIOSCOREA VILLOSA ROOT
- .ALPHA.-TOCOPHEROL ACETATE
- COCAMIDOPROPYL BETAINE
- BENZYL ALCOHOL
- SODIUM FLUORIDE
- FLUORIDE ION
- POTASSIUM NITRATE
- NITRATE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83592-816 | 83592-816-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 27eb3a1d-a874-af38-e063-6394a90abda0 | bc076e87-c14b-4597-ad39-1658b2ce8a35 | 2024-11-27 | Warnings | bc076e87-c14b-4597-ad39-1658b2ce8a35 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.