Label: PROVETI DENTI PREMIUM- potassium carbonate liquid

  • NDC Code(s): 86157-0001-1
  • Packager: SUN LIFE SCIENCE Co.,Ltd.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 8, 2022

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  • ACTIVE INGREDIENT

    Chitosan(Poliglusam), Propolis Wax(Extract)

  • INACTIVE INGREDIENT

    water, ascorbic acid, stevioside, arginine, glycerin, tocopherol, dipropylene glycol, zantnoxylum piperitum fruit extract, pulsatilla koreana extract, usnea barbata (lichen) extract

  • PURPOSE

    Mouthwash for pets and Get rid of bad breath.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Do not spray deep into the mouth, but spray on the molars and gums.

    If it's hard to open your mouth, spray it around your mouth to encourage you to lick it.

    Spray it to the mouth at least once or twice a day.

  • WARNINGS

    A. Side effects
    (1) Consult a veterinarian in case of any of the following abnormalities in use.If you have red spots, swelling, itching, or irritation during use.

    B. Contraindications
    Do not use it in areas with wounds.

    C. Precautions for how to use it.
    (1) If it goes into your eyes, wash it immediately.

    D. Other precautions
    (1) Store in a dry place after use.
    (2) Store out of reach of infants and children.
    (3) Do not store it in a hot or low temperature place or in a place where sunlight contacts.

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    SUN LIFE LABEL

  • INGREDIENTS AND APPEARANCE
    PROVETI DENTI PREMIUM 
    potassium carbonate liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86157-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLIGLUSAM (UNII: 82LKS4QV2Y) (POLIGLUSAM - UNII:82LKS4QV2Y) POLIGLUSAM1 g  in 100 mL
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86157-0001-150 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/08/2022
    Labeler - SUN LIFE SCIENCE Co.,Ltd. (695149648)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUN LIFE SCIENCE Co.,Ltd.695149648api manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    PL COSMETIC688393375manufacture
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