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  5. Label Information: Mastikis Fresh Gargle

FDA Label for Mastikis Fresh Gargle

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. STOP USE AND ASK A DENTIST IF
    6. KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL

Mastikis Fresh Gargle Product Label

The following document was submitted to the FDA by the labeler of this product Mastic Korea.co.ltd. 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.

Active Ingredient



Cetylpyridinium chloride 0.05%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



Ask a dentist before use if
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.


Stop Use And Ask A Dentist If



  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  •  children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use consult a dentist or doctor

Other Information



  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients



Glycerin, Xylitol, Steviol Glycoside, Trisodium Citrate, Ascorbic Acid, L-Menthol, Green Tea Extract, Mastic Oil, Lemon Mint Flavor, Sodium Benzoate, Hydrogenated Caster Oil, Deionized Water


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