FRAICHE 5000 SENSITIVE- sodium fluoride,potassium nitrite gel 
True Marker Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Drug Facts

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

image descriptionimage description

FRAICHE 5000 SENSITIVE 
sodium fluoride,potassium nitrite gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:83592-816
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XYLITOL (UNII: VCQ006KQ1E)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)  
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83592-816-041 in 1 CARTON03/12/2024
1122 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/12/2024
Labeler - True Marker Pharmaceuticals, Inc. (119046582)

Revised: 3/2024
Document Id: 13a513b1-ffcb-e135-e063-6394a90ae7b1
Set id: bc076e87-c14b-4597-ad39-1658b2ce8a35
Version: 1
Effective Time: 20240314
 
True Marker Pharmaceuticals, Inc.