Active Ingredient
Stannous Fluoride 0.4%
(0.12% w/v fluoride ion)
Home Care Fluoride Gel
FDA Label NDC 55346-0404
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dental Technologies, Inc. for the product Home Care Fluoride (NDC 55346-0404). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 or 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 the 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
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alpha-dent®
HOME CARE
FLUORIDE GEL
0.4% STANNOUS FLUORIDE
AIDS IN THE
PREVENTION
OF DENTAL CAVITIES
STRAWBERRY
REF 004-0401-001
NET WEIGHT - 4.3 oz. (121.9g)
DENTAL
TECHNOLOGIES
6901 N HAMLIN AVENUE
LINCOLNWOOD, ILLINOIS 60712 USA
www.dentaltech.com
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