FDA.reportPublic FDA data

Dentalclean Ultra Refreshing Extreme Ice Dental Gel

Manufacturer
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
Effective date
2024-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:09

Label at a glance#

ProductDentalclean Ultra Refreshing Extreme Ice Dental Gel
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

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

  • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor

INACTIVE INGREDIENT SECTION

Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)

OTHER SAFETY INFORMATION

Store in a dry, cool place away from sunlight.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
84035-001-01Dentalclean Ultra Refreshing Extreme Ice Dental Gel50 g in 1 TUBEPASTE, DENTIFRICE501
84035-001-01Dentalclean Ultra Refreshing Extreme Ice Dental Gel1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84035-001DENTALCLEAN ULTRA REFRESHING EXTREME ICE DENTAL GEL (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [RABBIT INDÚSTRIA E COMÉRCIO DE PRODUTOS DE HIGIENE PESSOAL LTDA]1Current NDC, 2 package rows20240601_1496636d-6563-d474-e063-6394a90ab73d.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
84035-00184035-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDE ANHYDROUS6BR7T22E2SIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
MENTHOLL7T10EIP3AIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT

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 Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
ndc (package): 84035-001-01
ndc (product): 84035-001
ndc11 (package): 84035000101
spl id: 1496636d-6564-d474-e063-6394a90ab73d
spl set id: 1496636d-6563-d474-e063-6394a90ab73d

Reported adverse events (FAERS/openFDA)#

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