NDC 24765-134 Killfire Mouth Freshener

Cetylpyridinium Chloride

NDC Product Code 24765-134

NDC 24765-134-01

Package Description: 20 mL in 1 BOTTLE, SPRAY

NDC Product Information

Killfire Mouth Freshener with NDC 24765-134 is a a human over the counter drug product labeled by Pharmacal-international. Co., Ltd.. The generic name of Killfire Mouth Freshener is cetylpyridinium chloride. The product's dosage form is spray and is administered via oral form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Killfire Mouth Freshener Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmacal-international. Co., Ltd.
Labeler Code: 24765
FDA Application Number: part356 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-29-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Killfire Mouth Freshener Product Label Images

Killfire Mouth Freshener Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Oral Antiseptic

Use

  • Helps remove plaque Helps remove bad breathClean 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

* Please review the disclaimer below.