Oral Defense Fluoride Rinse
FDA Label NDC 52644-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oral Defense, Llc for the product Oral Defense Fluoride Rinse (NDC 52644-002). 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 drug facts, purpose, uses, warnings, keep out of the reach of children., directions, inactive ingredients, labels, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Sodium Fluoride .05% (0.22% w/v fluoride ion)

Purpose

Anti-cavity

Uses

Aids in the prevention of dental cavities

Warnings

Do not swallow. In case of accidental ingestion, seek medical help or contact a poison control center immediately. Cold weather may cloud this product. Properties are not affected.

Keep Out Of The Reach Of Children.

Directions

Adults and children 6 years of age and older

  • Use once a day, preferably before bedtime, after brushing and flossing thoroughly.
    • For mature adults with gum recession, it is beneficial to use an interdental proxy brush (toothpick type plastic brush) to remove all food debris between all teeth.
      • Use 10ml (1/3oz) and vigorously swish between the teeth for 1 minute. Spit out. Do not swallow.
        • Supervise children over 6 years of age until capable of suing without supervision.
          • Consult with a dentist or doctor for use with children under 6 years of age.
            • Do not take in food or drink for 30 minutes after application.

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, flavor, versene, cetylpyridinium chloride, sodium lauroyl sarcosinate, sodium saccharin, sodium hydroxide, citric acid, natamycin, FD and C green #5, FD and C red #33.

Labels

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