Autobrush Kids Strawberry Liquid
FDA Label NDC 82913-009

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 Kids Strawberry (NDC 82913-009). 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

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.

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, Xylitol, Cellulose Gum, Strawberry Flavor, Stevia Rebaudiana Leaf Extract
Potassium Sorbate, Sodium Benzoate, Sodium Bicarbonate, Calcium Citrate

Product Label

Image Description (Image 009)

Image Description (Image 009)

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