Label: BAD BREATH KILLER- propolis strip

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

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Drug Label Information

Updated August 17, 2021

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  • ACTIVE INGREDIENT

    Propolis extract 8.29%

  • PURPOSE

    Antibacterial

  • Uses

    ■ Helps prevent and reduce oral bacterial that leads to bad breath, gingivitis, periodontitis
    ■ For the dry mouth relief overnight

  • WARNINGS

    Use with caution if allergic to bee products
    Keep out of reach of children under 3 years age

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 3 years age

  • Directions

    ■ Use 1 strip per day or per night.
    ■ Fold and apply to upper molar gum surface
    ■ Do not push the strips with tongue for 10 second once applied.
    ■ Safe to use overnight

  • Other Information

    Store away from high temperatures and humidity or direct sunlight.

  • QUESTIONS

    ■ www.tecozyme.com or contact@tecozyme.com

  • INACTIVE INGREDIENTS

    Hydroxypropyl Methylcellulose, Zinc gluconate, Glycerin Vitamin E, L-Arginine, β- Cyclodextrin, Fragrance, Hyaluronic acid, Glycerin Esters of Fatty Acids, Xylitol, licorice concentrated powder, Cinnamon extract powder, Bokbunja (Wild raspberry) extract, Palm oil, Enzyme-treated stevia, Vitamin B12, Salt, Aspartame

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BAD BREATH KILLER 
    propolis strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79717-0011
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX8.29 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Zinc gluconate (UNII: U6WSN5SQ1Z)  
    Xylitol (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79717-0011-214 in 1 CARTON08/01/2021
    1NDC:79717-0011-184.5 mg in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2021
    Labeler - TECOZYME INC (694613703)
    Registrant - TECOZYME INC (694613703)
    Establishment
    NameAddressID/FEIBusiness Operations
    CL Pharm Co.,Ltd.694759867manufacture(79717-0011)
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