Brushbuddies Shopkins Anticavity Fluoride
FDA Label NDC 70108-502

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 Fluoride (NDC 70108-502). 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, storage and handling, inactive ingredient, 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 Fluoride 0.05%

Otc - Purpose

Purpose:

Anticavity

Indications & Usage

Uses:

Helps protect 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

Dosage & Administration

Directions:

  • Adults and children 6 years and older:
  • Use daily after your normal brush
  • Shake well before each use
  • Rinse or gargle for 30 seconds with 15 mL (3 teaspoonful) and then spit out
  • Supervise children's brushing untill good habits are established.
  • Do not Swallow the rinse

Storage And Handling

Other Information

Store in cool and dry place away from direct sun light

Inactive Ingredient

Inactive Ingredients:

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

Package Label.Principal Display Panel

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