Active Ingredient
Sodium Fluoride 0.243%
Autobrush Bubblegum Gel
FDA Label NDC 82913-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lander Enterprises, Llc for the product Autobrush Bubblegum (NDC 82913-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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
Image Description (Image 1 005)
Image Description (Image 2 005)
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