Brushbuddies Shopkins Anticavity Tooth
FDA Label NDC 70108-501

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studio Inc for the product Brushbuddies Shopkins Anticavity Tooth (NDC 70108-501). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Sodium Monofluorophosphate 0.5%

Otc - Purpose

Purpose:

Anticavity

Indications & Usage

Uses:

Help protect teeth and roots against cavities

Warnings

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age

Dosage & Administration

Directions:

  • Adults and children 2 years and older:
  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow
  • To minimize swallowing use a pea-sized amount in children under 6 years of age,
  • Supervise children's brushing untill good habits are established.

    • Children under 2 years of age:

    • Ask a dentist

Inactive Ingredient

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Sodium Pyrophosphate, Saccharin Sodium, Rose Red 1

Package Label.Principal Display Panel

Image Description (Qq20161202232746)

Image Description (Qq20161202232746)

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