BIOREPAIR SENSITIVE TEETH- dicalcium phosphate dihydrate paste 
Coswell Spa

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Contains:

Dicalcium Phosphate Dihydrate (0.6289 fl. oz.)

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

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.

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

For daily usage.

For daily usage.

Warnings

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BIOREPAIR SENSITIVE TEETH 
dicalcium phosphate dihydrate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-006
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) ANHYDROUS DIBASIC CALCIUM PHOSPHATE18.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70781-006-0175 g in 1 TUBE; Type 0: Not a Combination Product06/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/02/2017
Labeler - Coswell Spa (429512304)
Establishment
NameAddressID/FEIBusiness Operations
Incos Cosmeceutica Industriale Srl434933032manufacture(70781-006)

Revised: 6/2017
Document Id: 51da281d-bfe4-7482-e054-00144ff8d46c
Set id: 5101fced-e1da-0ac2-e054-00144ff8d46c
Version: 3
Effective Time: 20170613
 
Coswell Spa