FDA Label for Cleararc
View Indications, Usage & Precautions
Cleararc Product Label
The following document was submitted to the FDA by the labeler of this product Den-mat Holdings, Llc. 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
Aids in the prevention of dental cavities.
Warnings
This is an anticavity fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.
Using this product may produce surface staining of the teeth. Adequate tooth brushing may prevent stains which are not harmful or permanent and may be removed by a dentist.
Keep Out Of Reach Of Children Section
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 and older: Use once daily after brushing.
- Apply a thin line of gel to each custom tray. Place firmly over teeth. After wearing trays for 1 minute, remove and spit out any remaining gel. Do not swallow. Do not eat or drink for 30 minutes.
- Instruct children under 12, in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
- Children under 6, consult a dentist or doctor.
Other Information
For your protection, do not use if the tip under the cap is cut or tampered.
Inactive Ingredients
Ascorbc Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine
Questions Or Comments?
877-9-CLEARARC
Principal Display Panel
ClearArc®
Clinical Strength
Cavity Protection Gel
Formulated with Stannous Fluoride
Mint Flavor
NET WT. 4 OZ. (113.4 G)
* Please review the disclaimer below.