NDC 63148-019 Giant Eagle Cool Burst Antiseptic

NDC Product Code 63148-019

NDC 63148-019-33

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Giant Eagle Cool Burst Antiseptic with NDC 63148-019 is a product labeled by Apollo Health And Beauty Care Inc.. The generic name of Giant Eagle Cool Burst Antiseptic is . The product's dosage form is and is administered via form.

Labeler Name: Apollo Health And Beauty Care Inc.

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)

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
Start Marketing Date: 09-11-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Giant Eagle Cool Burst Antiseptic Product Label Images

Giant Eagle Cool Burst Antiseptic 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 togingivitisbleeding gums

Warnings

  • Stop use and ask a dentist ifgingivitis, bleeding, or redness persists fore more than 2 weeksyou have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs 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 usechildren under 6 years of age: do not use

Other Information

  • This rinse is not intended to replace brushing or flossingstore 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.