Otc - Active Ingredient
Active Ingredient
Stannous fluoride 0.1%
Medactive Patient Friendly
FDA Label NDC 49741-1005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Integrate Oral Care, Llc. for the product Medactive Patient Friendly (NDC 49741-1005). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other safety information, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Cavity protection
Indications & Usage
Uses
- Aids in the prevention of dental decay.
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.
Dosage & Administration
Directions
Use immediately after preparing the rinse as follows:
Adults and children 6 years or 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.
- See Rinse or box for expiration date.
Inactive Ingredient
Inactive Ingredients
dimethicone, EDTA, FD&C Green No. 3, flavor (includes Spilanthes Extract), glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbitol, sucralose, water
Otc - Questions
Questions or comments?
1-866-877-4876 M-F 9am-5pm EST or www.integrateoralcare.com
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Package Label.Principal Display Panel
Orange Crème With Ultramulsion® & Spilanthes Extract (Marin2oc 10 349741100526 Fda)
Patient-Friendly™ Orange Crème
Stannous Fluoride Rinse with ULTRAMULSION ® & Spilanthes Extract
10 DOSE PACKS
IMPORTANT
Read directions for proper use.
NET CONTENTS: 10 DOSE PACKS 10.4 FL OZ (307 mL)
NDC 49741-1005-2
MedActive® Oral Care Redefined ™
Patient-Friendly™ Orange Crème
Stannous Fluoride Rinse with ULTRAMULSION ® & Spilanthes Extract
30 DOSE PACKS
IMPORTANT
Read directions for proper use.
NET CONTENTS: 30 DOSE PACKS 31.2 FL OZ (923 mL)
NDC 49741-1005-3
Orange Crème With Ultramulsion® & Spilanthes Extract (Marin2oc 30 349741100533 Fda)
* Please review the disclaimer below.
