FDA.reportPublic FDA data

Giant Eagle Cool Burst Antiseptic

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2019-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:16

Label at a glance#

ProductGiant Eagle Cool Burst Antiseptic
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 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.

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).

Labe copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-019-332021-01-29C16284748780-1ba0f9c33-54d4-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-019-33Giant Eagle Cool Burst Antiseptic1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-019GIANT EAGLE COOL BURST ANTISEPTIC (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20190913_0060781a-1a2a-41af-ab6f-873eec515756.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-01963148-019-33

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
NameUNIIKind
EUCALYPTOLRV6J6604TKACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C GREEN NO. 33P3ONR6O1SIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
056eb9db-5a91-449f-a136-6fe8271977f80060781a-1a2a-41af-ab6f-873eec5157562019-09-12WarningsExact identifier
spl id: 056eb9db-5a91-449f-a136-6fe8271977f8
spl set id: 0060781a-1a2a-41af-ab6f-873eec515756

Reported adverse events (FAERS/openFDA)#

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