Otc - Active Ingredient
Active ingredients
Sodium Fluoride 0.22% (0.10% w/v fluoride ion)
Mediterra Gum Tooth Paste, Dentifrice
FDA Label NDC 88011-010
10 label sections · Submitted to the FDA by Proval · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proval for the product Mediterra Gum Tooth (NDC 88011-010). 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, otc - keep out of reach of children, dosage & administration, other safety information, 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
Anticavity
Indications & Usage
Uses
Helps prevent gum disease and plaque
Strengthens and whitens teeth
Freshens breath
Helps prevent cavities (fluoride)
Warnings
Warnings
Contains 1,000 ppm fluoride.
If irritation occurs, stop use and consult a dentist.
If a child under 6 swallows more than used for brushing, get medical help.
Do not swallow; rinse after brushing. Children 6 and under: use a pea-sized amount under supervision.
Keep out of reach of young children.
Otc - Keep Out Of Reach Of Children
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Dosage & Administration
Directions
Apply an appropriate amount to a toothbrush and brush teeth thoroughly.
Other Safety Information
Other Information
Store in a cool, dry place.
Otc - Questions
Questions?
82-70-8018-9797 / [email protected]
Inactive Ingredient
Inactive ingredients
D-Sorbitol Solution, Water, Dental Type Silica, Concentrated Glycerin, Sodium Cocoyl Glutamate, Carboxymethylcellulose Sodium, Polyethylene Glycol 1500, Sodium Bicarbonate, Sodium Chloride, L-Menthol, Menthol Pulegium Oil, Herb Mint Flavor, Xylitol, Tocopherol Acetate, Enzymatically Modified Stevia, Pyridoxine Hydrochloride, Mastic Oil, Herb Flavor, Hydrolyzed Collagen, Lactic Acid Bacteria Fermented Solution, Green Tea Extract, Matricaria Extract, Centella Extract, Ginger Extract, Aloe Extract, Eucalyptus Extract, Calendula Extract, Scutellaria Root Extract, Myrrha Essence, Clove Oil, Rhatany Essence, Tea Tree Oil
Package Label.Principal Display Panel
MEDITERRA GUM TOOTHPASTE
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