Label: INSAN BAMBOOSALT TOOTHPASTE- calcium carbonate paste, dentifrice

  • 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 February 12, 2011

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  • ACTIVE INGREDIENT

    active ingredient: precipitated calcium carbonate
  • INACTIVE INGREDIENT

    inactive ingredient: silicon dioxide, dibasic calcium phosphate, aminocaproic acid, glycerine, D-sorbitol, sodium carboxymethylcellulose, sodium lauryl sulfate, polyethyleneglycol 4000, xylitol, L-menthol, chitosan, bamboo salt, steviol slycoside, peppermint oil, dionized water
  • PURPOSE

    for dental care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • DOSAGE & ADMINISTRATION

    brush your teeth by putting appropriate amount of tooth paste
  • WARNINGS

    do not use other than oral cavity
  • PRINCIPAL DISPLAY PANEL

    package label
  • INDICATIONS & USAGE

    Make teeth strong.  Clean and refresh oral cavity. Prevent dental cavities and bad breath.
    Prevent from gingivitis, paradentitis, periodontal disease and gum disease and anti plaque.
  • INGREDIENTS AND APPEARANCE
    INSAN BAMBOOSALT TOOTHPASTE 
    calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75958-1001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE31.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    AMINOCAPROIC ACID (UNII: U6F3787206)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    XYLITOL (UNII: VCQ006KQ1E)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75958-1001-1160 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/13/2011
    Labeler - Insan Bamboo Salt Inc (687931852)
    Registrant - Insan Bamboo Salt Inc (687931852)
    Establishment
    NameAddressID/FEIBusiness Operations
    Insan Bamboo Salt Inc687931852manufacture