Mastikis Fresh Gargle
FDA Label NDC 79814-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mastic Korea.co.ltd for the product Mastikis Fresh Gargle (NDC 79814-007). 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, warnings, stop use and ask a dentist if, keep out of reach of children under 6 years of age, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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