Active Ingredient
1.1% neutral sodium fluoride
Sodium Fluoride 1.1% Dental Gel Mint Gel
FDA Label NDC 71085-074
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ipg Pharmaceuticals, Inc. for the product Sodium Fluoride 1.1% Dental Gel Mint (NDC 71085-074). 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 active ingredient, uses, directions, warning, inactive ingredient, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
Directions
Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician.
Adults and Children 6 Years of Age and Older: Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all
sensitive areas of the teeth.
Dosage form and Strengths: Dental gel containing 1.1% sodium fluoride.
Warning
Contraindications: Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician.
Warnings and Precautions: Do no swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Adverse reactions: To report suspected
Adverse reactions, To report suspected adverse reactions, contact IPG Pharmaceuticals at (888) 711-7116 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Inactive Ingredient
Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sorbitol, Xanthan Gum, Flavor, Yucca Shidigera Root Extract, Quillaja
Saponaria Bark Extract, Smilax Aristolochiaefolia Root Extract, Dioscorea Villosa Root Extract, Tocopheryl Acetate, Cocamidopropyl Betaine,
Benzyl Alcohol.
Product Label
Image Description (Image 74)
Image Description (Image 74 1)
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