FDA.reportPublic FDA data

Dentalclean Regenerator Sensitive Dental Gel with Flouride

Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Effective date
2024-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:09

Label at a glance#

ProductDentalclean Regenerator Sensitive Dental Gel with Flouride
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 INGREDIENT SECTION

Glycerol, Silium Dioxide, Sorbitol, Water, Sodium Lauryl Sulphate, Aroma, Carmelose Sodium, Phoshoric Acid, Tetrassodium Pyrophosphate, Menthol, Mica, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose

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
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
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
84035-002-03Dentalclean Regenerator Sensitive Dental Gel with Flouride104 g in 1 TUBEPASTE, DENTIFRICE1041
84035-002-03Dentalclean Regenerator Sensitive Dental Gel with Flouride1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84035-002DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA]1Current NDC, 2 package rows20240601_176aa3ed-e2a4-536d-e063-6294a90aa097.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
84035-00284035-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDE ANHYDROUS6BR7T22E2SIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITOL506T60A25RIACT
MENTHOLL7T10EIP3AIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCEROL FORMAL3L7GR2604EIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
PHOSPHORIC ACIDE4GA8884NNIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
MICAV8A1AW0880IACT

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 Regenerator Sensitive Dental Gel with FlourideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972024-05-01WarningsExact identifier
ndc (package): 84035-002-03
ndc (product): 84035-002
ndc11 (package): 84035000203
spl id: 176aa46a-04c4-4fef-e063-6294a90a1a70
spl set id: 176aa3ed-e2a4-536d-e063-6294a90aa097