Aurora Fresh Burst

Manufacturer
Apollo Health and Beauty Care
Effective date
2016-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:19

Label at a glance#

ProductAurora Fresh Burst
Active ingredientEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Label structure8 sections

Indications and uses

to help redce and prevent plaque gingivitis

Dosage and administration

rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night. do not swallow.

Storage and handling

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

to help redce and prevent

  • plaque
  • gingivitis

Warnings

WARNINGS SECTION

Do not use in children under 12 years of age.

Keep out of reach of children.

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

  • rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • do not swallow.

Other informaton

STORAGE AND HANDLING SECTION

  • 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, Flavor, Poloxamer 407, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Yellow 10 (CI 47005), Green 3 (CI 42053).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-560-502024-01-30C16284748780-11030e365-1054-111a-e063-dadaa90a10e2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-560-50Aurora Fresh Burst1500 mL in 1 BOTTLE, PLASTICMOUTHWASH15001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-560AURORA FRESH BURST (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20160615_ffb10843-e1f5-4efd-a88f-5e1378591d15.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-56063148-560-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
8fd01b90-7898-451b-a3f7-aa6c8c85e476ffb10843-e1f5-4efd-a88f-5e1378591d152016-06-14WarningsExact identifier
spl id: 8fd01b90-7898-451b-a3f7-aa6c8c85e476
spl set id: ffb10843-e1f5-4efd-a88f-5e1378591d15

Reported adverse events (FAERS/openFDA)#

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