Active Ingredient
Sodium Fluoride 0.243%
Autobrush Mint Liquid
FDA Label NDC 82913-011
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 Mint (NDC 82913-011). 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:
- Shake before use.
- Gently dispense one pump on each side of your toothbrush head.
- (If using a manual toothbrush, you can dispense two pumps directly into your mouth.)
- Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
- Supervise children as necessary until capable of using without supervision.
Children under 2 years:
Consult a dentist or physician.
Inactive Ingredients
water, sorbitol, glycerin, poloxamer 407, sodium lauroyl sarcosinate, peg-40 hydrogenated castor oil, xylitol, cellulose gum, pepermint oil (flavor), stevia rebaudiana leaf extract, potassium sorbate, sodium benzoate, sodium bicarbonate, calcium citrate, menthol
Product Label
Image Description (Image 011)
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