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  5. Label Information: Oral Defense Fluoride Rinse

FDA Label for Oral Defense Fluoride Rinse

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF THE REACH OF CHILDREN.
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. LABELS

Oral Defense Fluoride Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Oral Defense, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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