Giant Eagle Cool Burst Mouthwash

Manufacturer: Apollo Health and Beauty Care Inc.
Effective date: 2019-02-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:58:40

Label at a glance#

ProductGiant Eagle Cool Burst Mouthwash

Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL

Label structure7 sections

Indications and uses

helps reduce plaque that leads to gingivitis bleeding gums

Dosage and administration

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.

Storage and handling

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiplaque/Antigingivitis

Uses

INDICATIONS & USAGE SECTION

helps reduce plaque that leads to

gingivitis
bleeding gums

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the label

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1043619	Eucalyptol/Menthol/Methyl salicylate/Thymol (Mouthwash)	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	PSN	1
1043619	eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML Mouthwash	SCD	1
1043619	eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % Mouthwash	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63148-569-50	2021-01-29	C162847	48780-1	ba0f9c33-1ade-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63148-569-50	Giant Eagle Cool Burst Mouthwash	1500 mL in 1 BOTTLE, PLASTIC	LIQUID	1500		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63148-569	GIANT EAGLE COOL BURST MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE INC.]	1	Legacy NDC, 1 package rows	20190301_71116029-886c-46df-b802-6c0d1dfa66ec.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Giant Eagle Cool Burst Mouthwash
Eucalyptol, Menthol, Methyl Salicylate, Thymol
EUCALYPTOL
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID
THYMOL
WATER
ALCOHOL
SORBITOL
POLOXAMER 407
BENZOIC ACID
SODIUM BENZOATE
SACCHARIN SODIUM
FD&C GREEN NO. 3

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63148-569	63148-569-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EUCALYPTOL	RV6J6604TK	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
THYMOL	3J50XA376E	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
SORBITOL	506T60A25R	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e3758897-db4d-418f-a278-d4f31ed12a2d			71116029-886c-46df-b802-6c0d1dfa66ec	2019-02-28	Warnings	Exact identifier spl id: e3758897-db4d-418f-a278-d4f31ed12a2d spl set id: 71116029-886c-46df-b802-6c0d1dfa66ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.