Aurora Alcohol Free Clean Mint

Manufacturer
Apollo Health and Beauty Care
Effective date
2016-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:16

Label at a glance#

ProductAurora Alcohol Free Clean Mint
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure8 sections

Indications and uses

Helps reduce and prevent plaque and gingivitis. Helps control bacteria plaque that contributes to the development of gingivitis and bleeding gums.

Dosage and administration

Use after your normal brushing and flossing routein; rinse toothpaste from mouth prior to use. ​Adults and children 6 years of age and older: ​ Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. do not swallow. children 6 years to under 12 years of age: supervise use. ​children under 6 years of age: do not use.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antiplaque/Antigingivitis

Uses

INDICATIONS & USAGE SECTION

  • Helps reduce and prevent plaque and gingivitis.
  • Helps control bacteria plaque that contributes to the development of gingivitis and bleeding gums.

Warnings

WARNINGS SECTION

Ask a dentist if symptoms persist or condition worsens after regular use.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Use after your normal brushing and flossing routein; rinse toothpaste from mouth prior to use.
  • ​Adults and children 6 years of age and older:​ Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day.
  • do not swallow.
  • 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

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

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
1100924cetylpyridinium chloride 0.07 % Oral RinsePSN1
1100924cetylpyridinium chloride 0.7 MG/ML MouthwashSCD1
1100924cetylpyridinium chloride 0.07 % Oral RinseSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130067153947590GTIN-13: 0067153947590
EAN-13: 0067153947590
GTIN-12: 067153947590
UPC-A: 067153947590
GTIN storage (14 digits): 00067153947590
21365L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-553-502024-01-30C16284748780-11030e364-ff3f-111a-e063-dadaa90a10e2DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-553-50Aurora Alcohol Free Clean Mint1000 mL in 1 BOTTLE, PLASTICMOUTHWASH10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-553AURORA ALCOHOL FREE CLEAN MINT (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [APOLLO HEALTH AND BEAUTY CARE]1Legacy NDC, 1 package rows20160615_095b9ec1-94f6-4933-979c-7370ac2ad7c0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-55363148-553-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
256504f1-abbb-4e05-9886-e3c06eea6af1095b9ec1-94f6-4933-979c-7370ac2ad7c02016-06-15WarningsExact identifier
spl id: 256504f1-abbb-4e05-9886-e3c06eea6af1
spl set id: 095b9ec1-94f6-4933-979c-7370ac2ad7c0

Reported adverse events (FAERS/openFDA)#

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