FDA Label for Giant Eagle Cool Burst Antiseptic

View Indications, Usage & Precautions

Giant Eagle Cool Burst Antiseptic Product Label

The following document was submitted to the FDA by the labeler of this product Apollo Health And Beauty Care Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 fore more than 2 weeks
  • you 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 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).


Labe Copy




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