Label: KILLFIRE MOUTHWASH- sodium fluoride rinse

  • NDC Code(s): 24765-132-01
  • Packager: Pharmacal-International. Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 17, 2023

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  • Active ingredient

    Sodium Fluoride (0.02%)

    Purpose

    • Anticavity mouthwash

    Use

    • Aids in prevention of dental cavities

    Directions

    • Rinse mouth with this Killfire Mouthwash about 10~15ml for 30 seconds then expel

    Average daily dose

    •  Use twice a day after brushing, meals, and before social occasions.

    Warnings

    • Keep out of reach of children.
    • Children under 7 years or younger must have parent supervision.
    • Do not swallow. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Inactive Ingredients

    Sodium Fluoride, Allantoin, Glycerin, Xylitol, Acetic acid, Sodium acetate, Malic acid, Sodium Benzoate, GreenTea Extract, Sodium Saccharin, flavoring, Polyoxyethylenehardened castor oil, L-Menthol, Cacao Color, Purified water

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    KILLFIRE MOUTHWASH 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-132
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    RACEMENTHOL (UNII: YS08XHA860)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-132-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/25/2021
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecoworld Co .,ltd688735061manufacture(24765-132)
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