Label: KILLFIRE MOUTH FRESHENER- cetylpyridinium chloride spray

  • NDC Code(s): 24765-134-01
  • Packager: Pharmacal-International. Co., Ltd.
  • 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 November 2, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient

    Cetylpyridinium Chloride 0.05%

    Purpose

    Oral Antiseptic

    Use

    • Helps remove plaque 
    • Helps remove bad breath
    • Clean mouth

    Directions

    • Spray killfire mouth freshener in the mouth once or several times when oral cleaning is required, such as after meals or before conversation.

    Warnings

    1) Patients who are prone to allergic contact eczema.

    2) Someone who's sensitive to medicine.

    2. Stop using this product immediately and consult a doctor, dentist, or pharmacist in the following cases. Please keep this attached document as much as possible during consultation. 1) Mouth: In the event of mucosal hypersensitivity in the mouth, such as rash, urticaria, erosion (darkness), rarely the mouth, pharynx (part of the digestive tract between the mouth and esophagus), etc.,

    2) If you have a high fever or headache,

    3) If you feel nauseous,

    3. Other precautions when using this product.

    1) Use it according to the prescribed usage and capacity.

    2) Do not drink this product.

    3) If you drink it incorrectly, follow the pharmacist or doctor's instructions.

    4) Children under the age of 6 should not use it without the instructions of a pharmacist or doctor.

    4. Caution in saving.

    1) Keep it out of reach of children.

    2) Avoid direct sunlight and push it (close the lid) in a cool place with as little moisture as possible.

    3) Do not change it into other containers to prevent misuse (wrong use) and preserve quality.

    Storage method

    Airtight container, storage at room temperature (1~30℃).

    Expiration date

    Separately marked

    Inactive Ingredients

    Glycerin, Xylitol, Sodium Benzoate, Sodium Saccharin, Malic acid, Citric acid, Sodium citrate,
    GreenTea Extract, Floral mint, Polyoxyethylenehardened castor oil, L-Menthol, Propolis extract,
    Purified water

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    KILLFIRE MOUTH FRESHENER 
    cetylpyridinium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-134
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MALIC ACID (UNII: 817L1N4CKP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    RACEMENTHOL (UNII: YS08XHA860)  
    WATER (UNII: 059QF0KO0R)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-134-0120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/29/2021
    Labeler - Pharmacal-International. Co., Ltd. (557805060)
    Registrant - Pharmacal-International. Co., Ltd. (557805060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecoworld Co .,ltd688735061manufacture(24765-134)