NDC 63148-569 Giant Eagle Cool Burst Mouthwash

Eucalyptol, Menthol, Methyl Salicylate, Thymol

NDC Product Code 63148-569

NDC Code: 63148-569

Proprietary Name: Giant Eagle Cool Burst Mouthwash What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Eucalyptol, Menthol, Methyl Salicylate, Thymol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 63148 - Apollo Health And Beauty Care Inc.
    • 63148-569 - Giant Eagle Cool Burst Mouthwash

NDC 63148-569-50

Package Description: 1500 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Giant Eagle Cool Burst Mouthwash with NDC 63148-569 is a a human over the counter drug product labeled by Apollo Health And Beauty Care Inc.. The generic name of Giant Eagle Cool Burst Mouthwash is eucalyptol, menthol, methyl salicylate, thymol. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Apollo Health And Beauty Care Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Giant Eagle Cool Burst 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.

  • EUCALYPTOL .92 mg/mL
  • MENTHOL .42 mg/mL
  • METHYL SALICYLATE .6 mg/mL
  • THYMOL .64 mg/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

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: Apollo Health And Beauty Care Inc.
Labeler Code: 63148
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: 02-27-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Giant Eagle Cool Burst Mouthwash Product Label Images

Giant Eagle Cool Burst 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 Ingredients

Eucalyptol 0.092%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antiplaque/Antigingivitis

Uses

  • Helps reduce plaque that leads to gingivitisbleeding gums

Warnings

  • Stop use and ask a dentist ifgingivitis, bleeding, or redness persists for more than 2 weeks.you have painful or swollen gums, pus from the gum line, loose theeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep Out Of Reach Of Children Under 6 Years Of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.Children 6 years to under 12 years of age: supervise use.Children under 6 years of age: do not use.

Other Information

  • This rinse is not intended to replace brushing or flossing.Store at room temperature. Cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients

Water (Aqua), Alcohol (21.6%), Sorbitol, Poloxamer 407, Flavor (Aroma), Benzoic Acid, Sodium Benzoate, Sodium Saccharin, Green 3 (CI 42053).

* Please review the disclaimer below.

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