Brushbuddies Barbie Anticavity Fluoridetooth
FDA Label NDC 71106-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Foshan Nanhai Jiachun Biology Engineering Co., Ltd. for the product Brushbuddies Barbie Anticavity Fluoridetooth (NDC 71106-003). 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 0.76%

Otc - Purpose

Purpose:

Anticavity Toothpaste

Indications & Usage

Uses:

Help protect teeth and roots against cavities

Warnings

Warnings:

If morethan used for brushing is 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

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 Lauryl Sulfate,  Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red 1

Package Label.Principal Display Panel

Image Description (Barbie)

Image Description (Barbie)

Image Description (Barbie)

Image Description (Barbie)

Image Description (Barbie)

Image Description (Barbie)

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