Label: BLANX WHITE SHOCK- sodium monofluorophosphate hydroxyapatite cetraria islandica paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 4, 2019

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SODIUM MONOFLUOROPHOSPHATE

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    CETRARIA ISLANDICA EXTRACT

    AQUA

    HYDROXYPATITE

    SORBITOL

    HYDRATED SILICA

    GLYCERIN

    SILICA

    ISOPROPYL ALCOHOL

    SODIUM LAURYL SULFATE

    CELLULOSE GUM

    AROMA

    CI 77891

    SODIUM SACCHARIN

    PVM/MA COPOLYMER

    SODIUM BENZOATE

    BENZYL ALCOHOL

    PHENOXYETHANOL

    CI 42090

  • PURPOSE

    Naturally whitens and removes
    bacteria that cause plaque and tooth decay

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    For best results use twice a day

  • INDICATIONS & USAGE

    For best results apply twice a day

  • WARNINGS

    WARNING..DO NOT SWALLOW

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    BLANX WHITE SHOCK 
    sodium monofluorophosphate hydroxyapatite cetraria islandica paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.82 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    Colorblue (CI 42090) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70781-002-0175 g in 1 TUBE; Type 0: Not a Combination Product08/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/14/2016
    Labeler - Coswell Spa (429512304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Incos Cosmeceutica Industriale Srl434933032manufacture(70781-002)
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