Label: GZE TOOTHPASTETABLETS (eugenia caryophyllus- clove leaf oil,menthol tablet, chewable

  • NDC Code(s): 83566-320-01
  • Packager: Guangzhou Yilong Cosmetics Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 30, 2024

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  • ACTIVE INGREDIENT

    Menthol 0.6%

    Eugenia Caryophyllus (Clove) Leaf Oil 5%

  • INACTIVE INGREDIENT

    Sorbitol

    Calcium Carbonate

    Kaolin

    Sodium Bicarbonate

    Mentha Piperita (Peppermint) Oil

    Stevia Rebaudiana Leaf Extract

    Flavor

  • PURPOSE

    Oral cleaning

  • INDICATIONS & USAGE

    Chew one tablet until it turns into a paste-like consistency. Wet your toothbrush and brush your teeth as usual with the toothpaste tablet paste. Rinse your mouth thoroughly with water.

  • WARNINGS

    For external use only.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Chew one tablet until it turns into a paste-like consistency. Wet your toothbrush and brush your teeth as usual with the toothpaste tablet paste. Rinse your mouth thoroughly with water.

  • PRINCIPAL DISPLAY PANEL

    product imagelabel

  • INGREDIENTS AND APPEARANCE
    GZE TOOTHPASTETABLETS 
    eugenia caryophyllus (clove) leaf oil,menthol tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.6 g  in 100 g
    CLOVE OIL (UNII: 578389D6D0) (CLOVE OIL - UNII:578389D6D0) CLOVE OIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)  
    SORBITOL (UNII: 506T60A25R)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Product Characteristics
    ColorgreenScoreno score
    ShapeROUNDSize11mm
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-320-0118 g in 1 BOTTLE; Type 0: Not a Combination Product08/18/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02208/18/2024
    Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co., Ltd712647107manufacture(83566-320)
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