Label: BLANX INTENSIVE STAIN REMOVAL- sodium monofluorophosphate, sodium fluoride 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

    Contains:

    Sodium Monofluorophosphate 0.4% (528 ppm F)

    Sodium Fluoride 0.08% (362 ppm F)

  • INACTIVE INGREDIENT

    Ingredients:

    Aqua, Glycerin, Hydrated Silica, Sorbitol, Silica, Cellulose Gum, Xylitol, Aroma, Cetraria Islandica Extract, Usnea Barbata Extract, Bambusa Arundinacea Stem Extract, Sodium Monofluorophosphate, Sodium Fluoride, Mentha Piperita Oil, Papain, Sodium Saccharin, Sodium Myristoyl Sarcosinate, Sodium Methyl Cocoyl Taurate, Sodium Benzoate, Phenoxyethanol, Benzyl Alcohol, Maltodextrin, Anethol, Menthol, Eugenol, Limonene, CI 77891.

  • PURPOSE

    Non-Abrasive Whitening Toothpaste

    Intensive Stain Removal

    Removes stubborn stains

    For daily use

    Complete dental care with Arctic Lichen for natural whitening

    BlanX Stain Prevention toothpaste containing Arctic Lichen cleans without abrasiveness, restoring the teeth's original whiteness day by day while combatin stains. Its unique formula enriched with microscopic bamboo powder removes stains and pigmentation due to smoking, food, beverages and plaque deposits.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    For daily use

  • INDICATIONS & USAGE

    For daily use

  • WARNINGS

    Warnings

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    BLANX INTENSIVE STAIN REMOVAL 
    sodium monofluorophosphate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70781-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.002 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ANETHOLE (UNII: Q3JEK5DO4K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM MYRISTOYL SARCOSINATE (UNII: J07237209D)  
    EUGENOL (UNII: 3T8H1794QW)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    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)  
    BAMBUSA BAMBOS STEM (UNII: NRA4497HC5)  
    PAPAIN (UNII: A236A06Y32)  
    USNEA BARBATA (UNII: D6DVA9TCAP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70781-003-0175 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(70781-003)