FDA Label for Medactive Patient Friendly
View Indications, Usage & Precautions
Medactive Patient Friendly Product Label
The following document was submitted to the FDA by the labeler of this product Integrate Oral Care, 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.
Otc - Active Ingredient
Active ingredient
Stannous fluoride 0.1%
Otc - Purpose
Purpose
Cavity protection
Indications & Usage
Uses
- Aids in the prevention of dental decay.
Warnings
Warnings
- When using this product, do not use longer than four weeks unless recommended by a medical doctor and/or dental professional.
- If more than used for rinsing is swallowed, seek medical attention or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Use immediately after preparing the rinse as follows:
Adults and children 6 years of age and older:
- Place both thumbs on Blue Chamber No. 1 and Press down firmly to squeeze fluoride into Chamber No. 2.
- Gently Shake.
- Snap Tab to Open by bending at line on the cap. Dispense half of mixture into the mouth and Rinse for 30 seconds. Spit.
- Gargle with remainder of mixture for 30 seconds. Spit.
- Avoid any food or drinks for at least 15 minutes after use.
- Consult your medical doctor and/or dental professional
Children under 6 years of age:
Other Safety Information
Other information
- This product may produce surface staining of the teeth.
- Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dental professional.
- Do not refrigerate. Store at room temperature.
Inactive Ingredient
Inactive Ingredients
dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilathes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water
Otc - Questions
Questions or comments?
1-866-877-4867 M-F 9am-5pm EST or www.medactive.com
Package Label.Principal Display Panel
MedActive® Oral Care Redefined™
Patient-Friendly™ Ruby Raspberry
Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract
10 DOSE PACKS
IMPORTANT Read directions for proper use.
NET CONTENTS: 10 DOSE PACKS 10.4 FL OX (307 mL)
NDC 49741-1007-2
MedActive® Oral Care Redefined™
Patient-Friendly™ Ruby Raspberry
Stannous Fluoride Rinse with ULTRAMULSION® & Spilanthes Extract
30 DOSE PACKS
IMPORTANT: Read directions for proper use.
NDC 49741-1007-3
* Please review the disclaimer below.