SODIUM FLUORIDE 1.1% DENTAL GEL MINT- sodium fluoride gel

Sodium Fluoride 1.1% Dental Gel MINT by

Drug Labeling and Warnings

Sodium Fluoride 1.1% Dental Gel MINT by is a Prescription medication manufactured, distributed, or labeled by IPG PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

1.1% neutral sodium fluoride

PURPOSE

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.

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.

KEEP OUT OF REACH OF CHILDREN

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.

SPL UNCLASSIFIED SECTION

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

Product label

INGREDIENTS AND APPEARANCE

SODIUM FLUORIDE 1.1% DENTAL GEL MINT 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71085-074
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
YUCCA SCHIDIGERA WHOLE (UNII: 08A0YG3VIC)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71085-074-02	1 in 1 CARTON	01/14/2025
1		200 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/14/2025

Labeler - IPG PHARMACEUTICALS, INC. (080441238)