FDA Label for Fraiche 5000 Kids Dental Bubble Gum
View Indications, Usage & Precautions
Fraiche 5000 Kids Dental Bubble Gum Product Label
The following document was submitted to the FDA by the labeler of this product True Marker Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
1.1% sodium fluoride
3% calcium hydroxyapatite
Purpose
Dental gel
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.
Warnings
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.
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 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
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
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?
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
* Please review the disclaimer below.
