Label: MASTIKIS FRESH GARGLE- cetylpyridinium chloride mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 21, 2020

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  • 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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  • INGREDIENTS AND APPEARANCE
    MASTIKIS FRESH GARGLE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79814-007-0220 in 1 PACKAGE09/21/2020
    1NDC:79814-007-0110 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/21/2020
    Labeler - Mastic Korea.Co.Ltd (687791189)
    Registrant - Mastic Korea.Co.Ltd (687791189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-007)
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