This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

How Supplied/Storage: 7.4 oz (200gm) in plastic tube. Store at room temperature 59-86°F (15-30°C)

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.

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.

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.

1.1% neutral sodium fluoride

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.

This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

How Supplied/Storage: 7.4 oz (200gm) in plastic tube. Store at room temperature 59-86°F (15-30°C)

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.

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.

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.

1.1% neutral sodium fluoride

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.