Label: BIOREPAIR TOTAL PROTECTION- dicalcium phosphate dihydrate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated June 13, 2017

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  • 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

    image

  • INGREDIENTS AND APPEARANCE
    BIOREPAIR TOTAL PROTECTION 
    dicalcium phosphate dihydrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE15.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70781-007-0175 g in 1 TUBE; Type 0: Not a Combination Product06/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/04/2017
    Labeler - Coswell Spa (429512304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Incos Cosmeceutica Industriale Srl434933032manufacture(70781-007)
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