Label: GZE MOUTHWASH- menthol,xylitol liquid

  • NDC Code(s): 83566-035-01, 83566-035-02
  • Packager: Guangzhou Yilong Cosmetics Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 4, 2024

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  • ACTIVE INGREDIENT

    Menthol
    Xylitol

    Citrus Aurantium Dulcis (Orange) Fruit Extract

  • INACTIVE INGREDIENT

    DISODIUM EDTA-COPPER
    DISODIUM EDTA-COPPER
    GLYCERIN
    SORBITOL
    SODIUM BENZOATE
    WATER
    POLYSORBATE 20
    METHYLPARABEN SODIUM

    Flavor

    CI 15985

  • INDICATIONS & USAGE

    Use after meals or when there is bad taste in the mouth, about 11ml each time, rinse all over the mouth, gums and teeth, and spit out after 20-30 seconds.

  • PURPOSE

    Sweet Mouthwash effectively cleans the mouth of food debris, reduces the growth of harmful oral bacteria, keeps breath fresh and makes teeth white. Sweet and fruity flavor, refreshing and non-iritating.

  • WARNINGS

    No swallowing

  • 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

    Use after meals or when there is bad taste in the mouth, about 11ml each time, rinse all over the mouth, gums and teeth, and spit out after 20-30 seconds.

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    GZE MOUTHWASH 
    menthol,xylitol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
    ORANGE OIL (UNII: AKN3KSD11B) (ORANGE OIL - UNII:AKN3KSD11B) ORANGE OIL2 g  in 100 mL
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-035-01250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2023
    2NDC:83566-035-02250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/15/2023
    Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co.,Ltd.712647107manufacture(83566-035)
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