Dentalclean Blue Diamond Alcohol Free Mouthwash

Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:11

Label at a glance#

ProductDentalclean Blue Diamond Alcohol Free Mouthwash
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children of 6 years of age and older: • Use once a day after brushing your teeth with a toothpaste. •Remove cap • Hold bottle upright and squeeze •Pour out •Vigorously swish between your teeth for 1 minute and then spit out • Do not swallow the rinse. • Do not eat or drink for 30 minutes after rinsing.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.05%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Useaids in the prevention of dental cavities

WARNINGS SECTION

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children of 6 years of age and older:

• Use once a day after brushing your teeth with a toothpaste.
•Remove cap
• Hold bottle upright and squeeze
•Pour out
•Vigorously swish between your teeth for 1 minute and then spit out
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.

OTHER SAFETY INFORMATION

Store in a dry, cool place away from sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerol, Ethoxylated Hydrogenated Rice Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Brilliant Blue (CI 42090)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackPacklabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84035-009-01Dentalclean Blue Diamond Alcohol Free Mouthwash1000 mL in 1 BOTTLERINSE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84035-009DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH (SODIUM FLUORIDE 0.05%) RINSE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA]1Current NDC, 1 package rows20240601_1881658c-e371-5513-e063-6394a90a465f.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
84035-00984035-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
ndc (package): 84035-009-01
ndc (product): 84035-009
ndc11 (package): 84035000901
spl id: 188167b2-4e8c-febc-e063-6294a90af681
spl set id: 1881658c-e371-5513-e063-6394a90a465f

Reported adverse events (FAERS/openFDA)#

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