FDA.reportPublic FDA data

BlanX White Shock

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 22:58:27

Label at a glance#

ProductBlanX White Shock
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

SODIUM MONOFLUOROPHOSPHATE

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

CETRARIA ISLANDICA EXTRACT

AQUA

HYDROXYPATITE

SORBITOL

HYDRATED SILICA

GLYCERIN

SILICA

ISOPROPYL ALCOHOL

SODIUM LAURYL SULFATE

CELLULOSE GUM

AROMA

CI 77891

SODIUM SACCHARIN

PVM/MA COPOLYMER

SODIUM BENZOATE

BENZYL ALCOHOL

PHENOXYETHANOL

CI 42090

OTC - PURPOSE SECTION

Naturally whitens and removes
bacteria that cause plaque and tooth decay

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

For best results use twice a day

INDICATIONS & USAGE SECTION

For best results apply twice a day

WARNINGS SECTION

WARNING..DO NOT SWALLOW

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70781-002-012021-01-29C16284748780-1ba0f9c33-38d6-a910-e053-dadaa90a0b85BlanX White Shock

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70781-002-01BlanX White Shock75 g in 1 TUBEPASTE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70781-002BLANX WHITE SHOCK (SODIUM MONOFLUOROPHOSPHATE HYDROXYAPATITE CETRARIA ISLANDICA) PASTE [COSWELL SPA]3Legacy NDC, 1 package rows20190205_3afb5721-e5f4-3fbf-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70781-00270781-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ISOPROPYL ALCOHOLND2M416302IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)389H2R62BDIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
CETRARIA ISLANDICA SUBSP. ISLANDICABJ7YPN79A1IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT

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
8112ae06-06e2-55ff-e053-2991aa0a97063afb5721-e5f4-3fbf-e054-00144ff88e882019-02-04WarningsExact identifier
spl id: 8112ae06-06e2-55ff-e053-2991aa0a9706
spl set id: 3afb5721-e5f4-3fbf-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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