Label: SOLMEET- calcium carbonate paste, dentifrice

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

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Drug Label Information

Updated December 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient: Calcium Carbonate, Dibasic Calcium Phosphate Hydrate, Aminocarproic Acid, Aluminium Chlorohydroxy Allantoinate
  • INACTIVE INGREDIENT

    Inactive ingredients: calcium carbonate, dibasic calcium phosphate hydrate, amonicaproic acid, aluminium chlorohydroxy allantoinate, glycerine, D-sorbitol, polyethylene glycol-1500, carboxymethylcellulose sodium, sodium lauryl sulfate, methylparaben, xylitol, L-menthol, peppermint oil, yellow no.5, blue no.1, angelica dahurica root extract, phellodendron bark extract, rosin, purified water
  • PURPOSE

    for dental care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    use when is needed
  • WARNINGS

    - do not swallow when using this product
    - if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away
  • DOSAGE & ADMINISTRATION

    apply proper amount on your toothbrush
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    SOLMEET 
    calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42352-3001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE15.85 g  in 100 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.6 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.05 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XYLITOL (UNII: VCQ006KQ1E)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    ROSIN (UNII: 88S87KL877)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42352-3001-1120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/15/2010
    Labeler - Solbin Co., Ltd (631099371)
    Registrant - Solbin Co., Ltd (631099371)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solbin Co., Ltd631099371manufacture
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