FDA Label for Home Care Fluoride
View Indications, Usage & Precautions
Home Care Fluoride Product Label
The following document was submitted to the FDA by the labeler of this product Dental Technologies, 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
Stannous Fluoride 0.4%
(0.12% w/v fluoride ion)
Purpose
Anticavity
Uses
Helps aid in the prevention of dental cavities.
Warnings
This is an anticavity fluoride preventive treatment gel, not a toothpaste.
Read directions carefully before using.
When Using This Product
it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.
Keep Out Of Reach Of Children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.
- Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6 years of age: Consult a dentist or doctor.
Other Information
Do not use if foil seal under the cap is torn, cut or missing.
Inactive Ingredients
Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine
Questions Or Comments?
1.800.835.0885 or 847.677.5500
Principal Display Panel
alpha-dent®
HOME CARE
FLUORIDE GEL
0.4% STANNOUS FLUORIDE
AIDS IN THE
PREVENTION
OF DENTAL CAVITIES
GRAPE
REF 004-0801-001
NET WEIGHT - 4.3 oz. (121.9g)
DENTAL
TECHNOLOGIES
6901 N HAMLIN AVENUE
LINCOLNWOOD, ILLINOIS 60712 USA
www.dentaltech.com
* Please review the disclaimer below.