NDC 24765-132 Killfire Mouthwash

Sodium Fluoride

NDC Product Code 24765-132

NDC 24765-132-01

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Killfire Mouthwash with NDC 24765-132 is a a human over the counter drug product labeled by Pharmacal-international. Co., Ltd.. The generic name of Killfire Mouthwash is sodium fluoride. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Pharmacal-international. Co., Ltd.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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 Mouthwash 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.

  • SODIUM FLUORIDE .02 g/100mL

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.

  • 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)

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: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-25-2021 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 Mouthwash Product Label Images

Killfire Mouthwash 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

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 expelAverage 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

* Please review the disclaimer below.