Dentalclean Sensitive Plus

Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Effective date
2024-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:10

Label at a glance#

ProductDentalclean Sensitive Plus
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without super...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24%

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 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.

• Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

OTHER SAFETY INFORMATION

Store in a dry, cool place away from sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Water, Silica, Sodium Lauryl Sulfate, Potassium Citrate Monohydrate, Sorbitol, Aroma, Carmellose Sodium, Tetrasodium Pyrophosphate, Titanium Dioxide, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, D-Limonene.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
84035-003-03Dentalclean Sensitive Plus1 in 1 CARTONPASTE, DENTIFRICE11
84035-003-03Dentalclean Sensitive Plus104 g in 1 TUBEPASTE, DENTIFRICE1041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84035-003DENTALCLEAN SENSITIVE PLUS (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA]1Current NDC, 2 package rows20240601_17e0dc93-97bf-7f05-e063-6294a90a9a8b.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84035-00384035-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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 Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
ndc (package): 84035-003-03
ndc (product): 84035-003
ndc11 (package): 84035000303
spl id: 17e0d926-0c40-8c0c-e063-6294a90af13f
spl set id: 17e0dc93-97bf-7f05-e063-6294a90a9a8b

Reported adverse events (FAERS/openFDA)#

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