Giant Eagle Cool Burst Mouthwash
FDA Label NDC 63148-569

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apollo Health And Beauty Care Inc. for the product Giant Eagle Cool Burst Mouthwash (NDC 63148-569). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children under 6 years of age., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick 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

  • gingivitis
  • bleeding gums

Warnings

Stop use and ask a dentist if

  • gingivitis, 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).

Label Copy

Image Of The Label (23566l)

Image Of The Label (23566l)

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