Oral Defense
FDA Label NDC 52644-001

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 (NDC 52644-001). 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, pupose, uses, warnings, keep out of the reach of children, directions, inactive ingredients, questions or comments, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Cetylpyridinium Chloride 0.1%

Pupose

Antigingivitus/Anti-Plaque

Uses

  • Canker sores
    • Dry mouth conditions
      • Oral lesions from chemo and radiation therapies
        • Diabetes
          • Gum irritations and disease
            • Lichen Plannus

Warnings

See a dentist if symptoms or conditions persist after regular use.

Keep Out Of The Reach Of Children

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.

Directions

Healthy Mouth

Rinse with 1 capful after brushing your teeth with Oral Defense toothpaste when needed for breath refreshment and to maintain healthy mouth tissue.

Red, Bleeding gums and inflamed mouth

For best and speedy results use with Oral Defense toothpaste. Use 1 capful after brushing with Oral Defense Toothpaste for 1 minute. If the lesions or sores re in one area, hold the capful of rinse in your mouth over the lesion for 1 minute, or if not possible to hold for 1 minute then use twice, 1 capful for 30 seconds each before spitting out. The most critical time of application is at bedtime, when no food or water is to be consumed after use, as the rinse has ingredients that have a long effective residual throughout the night when healing is best to occur.

Inactive Ingredients

purified water, glycerin, propylene glycol, sorbitol, polysorbate 80, poloxamer 407, mentha piperita (peppermint oil), versene, sodium lauroyl sarcosinate, sodium hydroxide, citric acid, menthol, natamycin, FD and C green #5

Questions Or Comments

1-800-355-9621

Manufactured Exclusively for Oral Defense, LLC Spokane, WA 99205

Labeling

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