FDA.reportPublic FDA data

Biorepair Sensitive Teeth

Manufacturer
Coswell Spa | Incos Cosmeceutica Industriale Srl
Effective date
2017-06-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:50:06

Label at a glance#

ProductBiorepair Sensitive Teeth
Active ingredientDIBASIC CALCIUM PHOSPHATE DIHYDRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Contains:

Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

INACTIVE INGREDIENT SECTION

Ingredients:

Aqua, Glycerin, Sorbitol, Cellulose Gum, PEG-32, Silica, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocyl Taurate, Aroma, Citric Acid, Sodium Saccharin, Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate

OTC - PURPOSE SECTION

Biorepair Plus Sensitive Teeth creates a natural barrier against hypersensitivity for a quick relief.

Biorepair Plus Sensitive Teeth is the toothpaste that contains microRepair, active biomimetic hydroxyapatite microparticles similar in composition to the teeth ones that are able to penetrate into micro-breaks, repair damaged enamel and occlude dentinal tubules.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Biorepair Plus Sensitive Teeth toothpaste can also be used by children under six years without the supervision of an adult, as it does not contain fluoride

DOSAGE & ADMINISTRATION SECTION

For daily usage.

INDICATIONS & USAGE SECTION

For daily usage.

WARNINGS SECTION

Warnings

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70781-006-012020-01-31C16284748780-19d75b9d0-8c80-f424-e053-dadaa90a57ce5101fced-e1da-0ac2-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70781-006-01Biorepair Sensitive Teeth75 g in 1 TUBEPASTE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70781-006BIOREPAIR SENSITIVE TEETH (DICALCIUM PHOSPHATE DIHYDRATE) PASTE [COSWELL SPA]3Legacy NDC, 1 package rows20170613_5101fced-e1da-0ac2-e054-00144ff8d46c.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
70781-00670781-006-01

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
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM MYRISTOYL SARCOSINATEJ07237209DIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPACTIM
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT

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
51da281d-bfe4-7482-e054-00144ff8d46c5101fced-e1da-0ac2-e054-00144ff8d46c2017-06-13WarningsExact identifier
spl id: 51da281d-bfe4-7482-e054-00144ff8d46c
spl set id: 5101fced-e1da-0ac2-e054-00144ff8d46c