FRAICHE 5000 SENSITIVE
Drug Facts
bc076e87-c14b-4597-ad39-1658b2ce8a35
HUMAN PRESCRIPTION DRUG LABEL
Mar 14, 2024
True Marker Pharmaceuticals, Inc.
DUNS: 119046582
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM FLUORIDE,POTASSIUM NITRITE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (16)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product label
INDICATIONS & USAGE SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Children under 6 years of age
Consult a dentist or physician.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (s)
Sodium Fluoride 1.1% and Potassium Nitrate 4.5%.
OTC - PURPOSE SECTION
WARNINGS SECTION
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.
SPL UNCLASSIFIED SECTION
How supplied/storage
4.3 ounces (122g) in plastic tube. Store at room temperature 59-86° F
(15-30 - °C)
DOSAGE & ADMINISTRATION SECTION
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.
INACTIVE INGREDIENT SECTION
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.