Label: BLANX WHITE SHOCK WHITE AND PROTECT- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL

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

    Contains:

    Sodium Monofluorophosphate 0.72% (950ppm F)

    *ActiluX®

  • INACTIVE INGREDIENT

    Ingredients:

    Aqua, Sorbitol, Hydrated Silica, Glycerin, Silica, Isopropyl Alcohol, Sodium Lauryl Sulfate, Cellulose Gum, Aroma, Hydroxyapatite*, Sodium Monofluorophosphate, PVM/MA Copolymer, Cetraria Islandica Extract, Sodium Saccharin, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Phenoxyethanol, CI 77891, CI 42090.

  • PURPOSE

    Whitening and Antibacterial Action

    The use of the BLANX LED helps to prevent gingivitis, halitosis and other common oral diseases

    The only ActiluX® based toothpaste, the double patented innovation that whitens with light.

    Now with Blue Formula for an immediate whitening effect*.

    ActiluX® is deposited on teeth and remains active throughout the day. Gives teeth the natural whiteness thanks to the light action.

    The use of the BlanX LED intensifies the antibacterial and hygiene action of the White Shock formula.

    It helps to prevent cavities, gingivitis, halitosis and other common oral diseases.

    Effectively removes the bacteria that causes plaque and cavities.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    For daily usage.

  • INDICATIONS & USAGE

    For daily usage.

  • WARNINGS

    Warnings

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    BLANX WHITE SHOCK WHITE AND PROTECT 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE (UNII: D9C330MD8B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70781-005-0150 g in 1 TUBE; Type 0: Not a Combination Product04/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/26/2017
    Labeler - Coswell Spa (429512304)
    Establishment
    NameAddressID/FEIBusiness Operations
    Incos Cosmeceutica Industriale Srl434933032manufacture(70781-005)
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