Label: SOLCO PLATINO IONDENTI TOOTH- aminocaproic acid paste

  • 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 June 14, 2018

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  • ACTIVE INGREDIENT

    Aminocaproic acid

  • INACTIVE INGREDIENT

    Xylitol, Calcium Hydrogen Phosphate

  • PURPOSE

    Toothpaste

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Take a proper amount of toothpaste to the toothbrush and brush it

  • WARNINGS

    If you have any problems, please consult your doctor.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SOLCO PLATINO IONDENTI TOOTH 
    aminocaproic acid paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72370-0002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.02 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72370-0002-13 in 1 CARTON06/12/2018
    11 in 1 CARTON
    1180 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/12/2018
    Labeler - SOLCO BIOMEDICAL CO., LTD. (687844241)
    Registrant - SOLCO BIOMEDICAL CO., LTD. (687844241)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOLCO BIOMEDICAL CO., LTD.687844241relabel(72370-0002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woorilife&Health694860803manufacture(72370-0002) , label(72370-0002) , pack(72370-0002)