FDA.reportPublic FDA data

BlanX Intensive Stain Removal

Manufacturer
Coswell Spa | Incos Cosmeceutica Industriale Srl
Effective date
2019-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:26

Label at a glance#

ProductBlanX Intensive Stain Removal
Active ingredientSODIUM FLUORIDE, SODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Contains:

Sodium Monofluorophosphate 0.4% (528 ppm F)

Sodium Fluoride 0.08% (362 ppm F)

INACTIVE INGREDIENT SECTION

Ingredients:

Aqua, Glycerin, Hydrated Silica, Sorbitol, Silica, Cellulose Gum, Xylitol, Aroma, Cetraria Islandica Extract, Usnea Barbata Extract, Bambusa Arundinacea Stem Extract, Sodium Monofluorophosphate, Sodium Fluoride, Mentha Piperita Oil, Papain, Sodium Saccharin, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Maltodextrin, Anethol, Menthol, Eugenol, Limonene, CI 77891.

OTC - PURPOSE SECTION

Non-Abrasive Whitening Toothpaste

Intensive Stain Removal

Removes stubborn stains

For daily use

Complete dental care with Arctic Lichen for natural whitening

BlanX Stain Prevention toothpaste containing Arctic Lichen cleans without abrasiveness, restoring the teeth's original whiteness day by day while combatin stains. Its unique formula enriched with microscopic bamboo powder removes stains and pigmentation due to smoking, food, beverages and plaque deposits.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

For daily use

INDICATIONS & USAGE SECTION

For daily use

WARNINGS SECTION

Warnings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1918252sodium fluoride 0.08 % / sodium monofluorophosphate 0.4 % ToothpastePSN3
1918252sodium fluoride 0.0008 MG/MG / sodium monofluorophosphate 0.004 MG/MG ToothpasteSCD3
1918252sodium fluoride 0.08 % / sodium monofluorophosphate 0.4 % ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70781-003-012021-01-29C16284748780-1ba0f9c33-572d-a910-e053-dadaa90a0b85BlanX Intensive Stain Removal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70781-003-01BlanX Intensive Stain Removal75 g in 1 TUBEPASTE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70781-003BLANX INTENSIVE STAIN REMOVAL (SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE) PASTE [COSWELL SPA]3Legacy NDC, 1 package rows20190204_4e2543f3-9d26-3d96-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70781-00370781-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
ANETHOLEQ3JEK5DO4KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
XYLITOLVCQ006KQ1EIACT
SODIUM MYRISTOYL SARCOSINATEJ07237209DIACT
EUGENOL3T8H1794QWIACT
LIMONENE, (+)-GFD7C86Q1WIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
CETRARIA ISLANDICA SUBSP. ISLANDICABJ7YPN79A1IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
BAMBUSA BAMBOS STEMNRA4497HC5IACT
PAPAINA236A06Y32IACT
USNEA BARBATAD6DVA9TCAPIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
8112ae06-06eb-55ff-e053-2991aa0a97064e2543f3-9d26-3d96-e054-00144ff8d46c2019-02-04WarningsExact identifier
spl id: 8112ae06-06eb-55ff-e053-2991aa0a9706
spl set id: 4e2543f3-9d26-3d96-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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