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 22, 2019

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  • ACTIVE INGREDIENT

    Calcium Carbonate

  • INACTIVE INGREDIENT

    glycerine, rosin, water, etc.

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    SOLMEET 
    calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70706-1004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE15.85 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ROSIN (UNII: 88S87KL877)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70706-1004-190 g in 1 TUBE; Type 0: Not a Combination Product05/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/12/2016
    Labeler - SOLM Co., Ltd. (689847034)
    Registrant - SOLM Co., Ltd. (689847034)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLM Co., Ltd.689847034manufacture(70706-1004)
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