Aqua Blue Mouthwash

Manufacturer
Body One Products Inc | BMC 1092,Inc dba Solo Laboratories, Inc
Effective date
2020-02-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:55

Label at a glance#

ProductAqua Blue Mouthwash
Active ingredientMethyl Salicylate, MENTHOL, UNSPECIFIED FORM, Eucalyptol, Thymol
Label structure8 sections

Dosage and administration

do not swallow not intended to replace brushing or flossing. Adults and children 12 years of age and older Vigorously swish 20mL between teeth twice a day for 30 seconds then spit out. children under 12 years of age consult a dentist or doctor

Storage and handling

Store at room temperature (59°-77°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Eucalyptol 0.092%Antiplaque/Antigingivitis
Menthol 0.042%Antiplaque/Antigingivitis
Methyl Salicylate 0.060%Antiplaque/Antigingivitis
Thymol 0.064%Antiplaque/Antigingivitis

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontis, a serious form of gum disease.

OTC - STOP USE SECTION

Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not swallow
  • not intended to replace brushing or flossing.
Adults and children 12 years of age and olderVigorously swish 20mL between teeth twice a day for 30 seconds then spit out.
children under 12 years of ageconsult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature (59°-77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Alcohol (21.6%),Polysorbate 80,Sorbitol,Flavor,Benzoic Acid,Sodium Saccharin,Sodium Benzoate,Blue 1,Yellow 5

PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BodyOne
Products

AQUA ⚬ BLUE

MOUTH WASH

1 U.S. Gallon (128 FL.OZ.)

PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label
PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug 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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73563-022-012024-01-30C16284748780-11030e365-5b02-111a-e063-dadaa90a10e2Aqua Blue Mouthwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73563-022-01Aqua Blue Mouthwash3785 mL in 1 JUGLIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73563-022AQUA BLUE MOUTHWASH (METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, EUCALYPTOL, AND THYMOL) LIQUID [BODY ONE PRODUCTS INC]1Legacy NDC, 1 package rows20200310_e4ddfdfd-e389-4b36-af84-755bc544505a.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
73563-02273563-022-01

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
0eb8ad36-cad6-457f-a1c9-9fa0c76b227ee4ddfdfd-e389-4b36-af84-755bc544505a2020-02-27WarningsExact identifier
spl id: 0eb8ad36-cad6-457f-a1c9-9fa0c76b227e
spl set id: e4ddfdfd-e389-4b36-af84-755bc544505a

Reported adverse events (FAERS/openFDA)#

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