Sparklefresh Paste, Dentifrice
FDA Label NDC 53329-083

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Sparklefresh (NDC 53329-083). 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, use, keep out of reach of children under 6 years of age., directions, inactive ingredients, questions, 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

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity Toothpaste

Use

Aids in the prevention of dental cavities

Keep Out Of Reach Of Children Under 6 Years Of Age.

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

Directions

  • Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years of age: consult a dentist or physician.

Inactive Ingredients

Calcium Carbonate, Carboxymethyl Cellulose, Flavor, Glycerin, Hydrated Silica, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Saccharin, Sorbitol, Tetrasodium Pyrophosphate, Water

Questions

1-800-MEDLINE

Principal Display Panel

Medline SparkleFresh Fluoride Toothpaste


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