Freshmint Premium Anticavity Gel Paste, Dentifrice
FDA Label NDC 51824-046

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Freshmint Premium Anticavity Gel (NDC 51824-046). 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, keep out of reach of children under 6 years of age, uses, warnings, directions, inactive ingredients, image of 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

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

Otc Purpose

Anticavity

Keep Out Of Reach Of Children Under 6 Years Of Age

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

Uses

Helps protect teeth and roots against cavities.

Warnings

Keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years & 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 until good habits are established.

    • Children under 2 years:

    • Ask a dentist

Inactive Ingredients

Sorbitol, Siliica, Treated Water, Polyethylene Glycol 1500, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, Methylparaben, Tetrasodium Pyrophosphate, Propylparaben, FD&C Blue # 1

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