Indications and uses
This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
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 an...
1.1% neutral sodium fluoride
Sodium Fluoride Dental Gel 1.1% is a flavored, pH neutral 1.1% sodium fluoride that aids in the prevention of dental decay and helps to treat sensitive teeth.
This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
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.
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.
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.
How Supplied/Storage: 7.4 oz (200gm) in plastic tube. Store at room temperature 59-86°F (15-30°C)
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71085-079-02 | Sodium Fluoride 1.1% Dental Gel BUBBLEGUM | 1 in 1 CARTON | GEL | 1 | 1 | |
| 71085-079-02 | Sodium Fluoride 1.1% Dental Gel BUBBLEGUM | 200 g in 1 TUBE | GEL | 200 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71085-079-02 | GM - Gram | 71085-079 | 3f4a0c9e-046d-403c-be64-51b79cc15181 | 1 | 2025-08-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71085-079 | 71085-079-02 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 58648ec8-6532-50e3-e063-6394a90af0cf | 5fb07d97-ce03-416f-a4a2-75c23cfebc05 | 2026-08-06 | Warnings | 5fb07d97-ce03-416f-a4a2-75c23cfebc05 |
Adverse event summaries are temporarily unavailable. Other product information remains available.