Label: BIOREPAIR SENSITIVE TEETH- dicalcium phosphate dihydrate paste

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 13, 2017

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  • 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

    image

  • INGREDIENTS AND APPEARANCE
    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)
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