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

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

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.

Uses

INDICATIONS & USAGE SECTION

For daily usage.

Warnings

WARNINGS SECTION

Warnings

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

For daily usage.

Other Label Information

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

Label Images#

94020180_DentiSensibili_Pack_bassa
94020180_DentiSensibili_Pack_bassa

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#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70781-00670781-006-01

Ingredients#

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

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Contains: Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

INACTIVE INGREDIENT SECTION

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

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

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

DOSAGE & ADMINISTRATION SECTION

For daily usage.

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

For daily usage.

WARNINGS SECTION

WARNINGS SECTION

Warnings

Source Document#

Source XML