PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

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INDICATIONS & USAGE SECTION

Uses

This 1.1% neutral sodium fluoride and 3% calcium hydroxyapatite dental gel is intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

DOSAGE & ADMINISTRATION SECTION

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 a 1-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.
Children under 6 years of age: Consult a dentist or physician.

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WARNINGS SECTION

Warnings

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. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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.

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OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (s)

Sodium Fluoride 1.1% and Calcium Hydroxyapatite 3%

OTC - PURPOSE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Children under 6 years of age

Consult a dentist or physician.

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SPL UNCLASSIFIED SECTION

How supplied/storage

4.3 ounces (122g) in plastic tube. Store at room temperature 59-86° F
(15-30 - °C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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.

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