Otc - Active Ingredient
Active Ingredient
Stannous Fluoride 0.1%
Medactive Patient Friendly Stannous Fluoride Rinse
FDA Label NDC 49741-1006
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 Stannous Fluoride Rinse (NDC 49741-1006). 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, indications & usage, warnings, dosage & administration, inactive ingredient, otc - questions, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- 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.
Other Information
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:
Inactive Ingredient
Inactive Ingredients
dimethocone, EDTA, FD&C Green No. 3, flavor, glycerin, poloxamer 407, potassium sorbate, sodium saccharin, sorbital, sucralose, water
Otc - Questions
Questions or comments?
1-866-887-4867 M-F 9 am - 5 pm EST or www.integrateoralcare.com
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Purpose
Purpose
Cavity Protection
Prinicpal Display Panel - 30 Dose Packs
Orange Creme With Ultramulsion (Marin2ocmf 30 349741100632 Fda)
Oral Care Redefined
Patient-Friendly
Orange Crème
Stannous Fluoride Rinse with ULTRAMULSION
Mild Formula
30 Dose Packs
NET CONTENTS: 30 DOSE PACKS 31.2 FL OZ (923 mL)
IMPORTANT: Read directions for proper use.
NDC 49741-1005-3
Principal Display Panel - 10 Dose Packs
Orange Creme With Ultramulsion10 (Marin2ocmf 10 349741100625 Fda)
Oral Care Redefined
Patient-Friendly
Orange Crème
Stannous Fluoride Rinse with ULTRAMULSION
Mild Formula
10 Dose Packs
NET CONTENTS: 10 DOSE PACKS 10.4 FL OZ (307 mL)
IMPORTANT: Read directions for proper use.
NDC 49741-1006-2
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