Burkhart Neutral
FDA Label NDC 43498-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Burkhart Dental Supply Inc for the product Burkhart Neutral (NDC 43498-301). 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:, warnings:, directions:, storage and handling, inactive ingredients:, 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

Active Ingredient:

1.1% Sodium Fluoride.

Purpose:

Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

Warnings:

Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

Directions:

Adults and children 6 years of age and older:

  • Twist off cap to remove foil seal.
  • Use once daily after brushing teeth thoroughly with toothpaste.
  • Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.
  • Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.

    • Children under 6 years of age:

    • Consult a dentist or physcian.

Storage And Handling

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

Package Label.Principal Display Panel

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