AUTOBRUSH BUBBLEGUM- sodium fluoride gel

AutoBrush bubblegum by

Drug Labeling and Warnings

AutoBrush bubblegum by is a Otc medication manufactured, distributed, or labeled by Lander Enterprises, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.243%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing
is accidentally swallowed, get medical help or contact a Poison Control Central right away.

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children 2 years and older:
Apply a pea-sized amount of toothpaste. When using an autobrush, split the pea-sized amount evenly across both sides of the brush head. Brush for 30 seconds using a side-to-side or figure-8 motion. With a manual or electric toothbrush, brush thoroughly for 2 minutes.

Children under 6:
Supervise brushing to teach good brushing habits and minimize swallowing.

Children under 2:
Consult a dentist or physician.

Inactive Ingredients

Water, Glycerin, Sorbitol, Xylitol, Hydrated Silica, Calcium Carbonate, Sodium Bicarbonate (Baking Soda), Sodium Cocoyl Glutamate (from Coconut), Cocos Nucifera (Coconut) Oil, Zinc Citrate, Natural Bubblegum Flavor, Cranberry Extract, Green Tea Extract, Aloe Vera, Potassium Chloride, Calcium Glycerophosphate, Sodium Benzoate.

Product label

INGREDIENTS AND APPEARANCE

AUTOBRUSH BUBBLEGUM 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82913-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CALCIUM CARBONATE (UNII: H0G9379FGK)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ZINC CITRATE (UNII: K72I3DEX9B)
CRANBERRY JUICE (UNII: Y74M3X3345)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82913-005-01	1 in 1 BOX	01/01/2026
1		100 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
OTC Monograph Drug	M021	01/01/2026

Labeler - Lander Enterprises, LLC (068619221)