Giant Eagle Cool Burst Antiseptic: Package Insert and Label Information

GIANT EAGLE COOL BURST ANTISEPTIC- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Apollo Health and Beauty Care Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

GIANT EAGLE COOL BURST ANTISEPTIC eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63148-019 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL SORBITOL POLOXAMER 407 BENZOIC ACID SODIUM BENZOATE SACCHARIN SODIUM FD&C GREEN NO. 3

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63148-019-33 1000 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 09/11/2019

Labeler — Apollo Health and Beauty Care Inc. (201901209)

Registrant — Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture (63148-019)

Revised: 09/2019 Apollo Health and Beauty Care Inc.