BIOREPAIR SENSITIVE TEETH- dicalcium phosphate dihydrate paste

Biorepair Sensitive Teeth by

Drug Labeling and Warnings

Biorepair Sensitive Teeth by is a Otc medication manufactured, distributed, or labeled by Coswell Spa, Incos Cosmeceutica Industriale Srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Contains:

Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

INACTIVE INGREDIENT

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

PURPOSE

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.

KEEP OUT OF REACH OF CHILDREN

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

For daily usage.

INDICATIONS & USAGE

For daily usage.

WARNINGS

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOREPAIR SENSITIVE TEETH 
dicalcium phosphate dihydrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	18.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-006-01	75 g in 1 TUBE; Type 0: Not a Combination Product	06/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/02/2017

Labeler - Coswell Spa (429512304)

Establishment
Name	Address	ID/FEI	Business Operations
Incos Cosmeceutica Industriale Srl		434933032	manufacture(70781-006)