BIOREPAIR TOTAL PROTECTION- dicalcium phosphate dihydrate paste

Biorepair Total Protection by

Drug Labeling and Warnings

Biorepair Total Protection 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 Dihyrate (0.5109 fl.oz)

INACTIVE INGREDIENT

Inactive Ingredients:

Aqua, Glycerin, Hydrated Silica, Sorbitol, Silica, Aroma, Cellulose Gum, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocyl Taurate, Citric Acid, Tetrapotassium Pyrophosphate, Zinc PCA, Sodium Saccharin, Benzyl Alcohol, Phenoxtethanol, Sodium Benzoate

PURPOSE

Biorepair Plus Total Protection protects every day natural dental health from acids erosion and from bacteria cause of plaque, tartar and tooth decay.

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

KEEP OUT OF REACH OF CHILDREN

Biorepair Plus Total Protection toothpaste can also be use by children under six years without the supervision of an adult, as it does not contain fluride

DOSAGE & ADMINISTRATION

For daily usage.

INDICATIONS & USAGE

For daily usage.

WARNINGS

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOREPAIR TOTAL PROTECTION 
dicalcium phosphate dihydrate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70781-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	15.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70781-007-01	75 g in 1 TUBE; Type 0: Not a Combination Product	06/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/04/2017

Labeler - Coswell Spa (429512304)

Establishment
Name	Address	ID/FEI	Business Operations
Incos Cosmeceutica Industriale Srl		434933032	manufacture(70781-007)