Label: PROBEE- propolis paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 December 28, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    propolis

  • INACTIVE INGREDIENT

    inactive ingredient: silica dioxide, sodium monofluorophosphate, sodium fluoride, sodium pyrophosphate, polyethylene glycol 1500, tocopherol acetate, sodium carboxymethyl cellulose, xylitol, hydrate sodium saccharine, green tea extract, menthol, green tea flavor, peppermint flavor, mint flavor, purified water

  • PURPOSE

    for dental care use

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    brush your teeth by putting appropriate amount of tooth paste

  • WARNINGS

    do not use other than oral cavity

  • DOSAGE & ADMINISTRATION

    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.

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    PROBEE 
    propolis paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76254-1001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q)  
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    MINT (UNII: FV98Z8GITP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76254-1001-150 g in 1 TUBE; Type 0: Not a Combination Product12/28/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2011
    Labeler - Seoul Propolis (687390351)
    Registrant - Seoul Propolis (687390351)
    Establishment
    NameAddressID/FEIBusiness Operations
    Seoul Propolis Co., Ltd.687390351manufacture(76254-1001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!