KILLFIRE MOUTH FRESHENER- cetylpyridinium chloride spray 
Pharmacal-International. Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

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

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
unapproved drug other10/29/2021
Labeler - Pharmacal-International. Co., Ltd. (557805060)
Registrant - Pharmacal-International. Co., Ltd. (557805060)
Establishment
NameAddressID/FEIBusiness Operations
Ecoworld Co .,ltd688735061manufacture(24765-134)

Revised: 8/2023
Document Id: 03243f48-b5ef-c0bb-e063-6394a90a3157
Set id: cf6c4ffc-fada-4737-ba9f-95540da42d0c
Version: 5
Effective Time: 20230817
 
Pharmacal-International. Co., Ltd.