Label: MOUTH RINSE- mentholum 0.02% menthone glycerin acetal 0.005% liquid

  • NDC Code(s): 83566-201-01, 83566-201-02, 83566-201-03, 83566-201-04, view more
    83566-201-05, 83566-201-06, 83566-201-07, 83566-201-08, 83566-201-09, 83566-201-10, 83566-201-11, 83566-201-12, 83566-201-13, 83566-201-14, 83566-201-15
  • Packager: Guangdong Aimu Biological Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • SPL UNCLASSIFIED SECTION

    MOUTH RINSE

  • ACTIVE INGREDIENT

    MENTHOLUM 0.02% MENTHONE GLYCERIN ACETAL 0.005%

  • PURPOSE

    Clean the oral cavity and prevent oral diseases

  • INDICATIONS & USAGE

    Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.

  • WARNINGS

    Do not swallow, please keep out of reach of children.
    For use only by people aged six and above.

  • DO NOT USE

    Do not use under the age of six, and do not use if there is a wound in the mouth.

  • WHEN USING

    Directions:Wash your mouth for 30 secondsbefore spitting out. Do not swallow.

  • STOP USE

    If adverse reactions occur during use, please seek medical assistance immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Applicable population: Children over 6 years oldStorage conditions: Store in a cool and dry place,avoiding direct sunlight

  • STORAGE AND HANDLING

    Storage conditions: Store in a cool and dry place,avoiding direct sunlight

  • INACTIVE INGREDIENT

    WATER
    CETYLPYRIDINIUM CHLORIDE
    POLOXAMER 407
    POTASSIUM SORBATE
    SUCRALOSE
    SODIUM BENZOATE
    SODIUM SACCHARIN
    CITRIC ACID
    CI42090

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MOUTH RINSE 
    mentholum 0.02% menthone glycerin acetal 0.005% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.02 g  in 100 mL
    MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP) (MENTHONE 1,2-GLYCEROL KETAL, (+/-)- - UNII:7QQ1EE6RCP) MENTHONE 1,2-GLYCEROL KETAL, (+/-)-0.005 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN (UNII: FST467XS7D)  
    DISODIUM N-ETHYL-N-4-((4-(ETHYL((3-SULFOPHENYL)METHYL)AMINO)PHENYL)(2-SULFOPHENYL)METHYLENE)-2,5-CYCLOHEXADIEN-1-YLIDENE)-3-SULFOBENZENEMETHANAMINIUM (UNII: PPQ093M8HR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-201-0110 mL in 1 DOSE PACK; Type 0: Not a Combination Product11/21/2023
    2NDC:83566-201-0212 mL in 1 CUP; Type 0: Not a Combination Product11/21/2023
    3NDC:83566-201-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    4NDC:83566-201-0480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    5NDC:83566-201-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    6NDC:83566-201-06120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    7NDC:83566-201-07180 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    8NDC:83566-201-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    9NDC:83566-201-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    10NDC:83566-201-10450 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    11NDC:83566-201-11480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    12NDC:83566-201-12500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    13NDC:83566-201-131000 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    14NDC:83566-201-141438 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    15NDC:83566-201-151500 mL in 1 BOTTLE; Type 0: Not a Combination Product11/21/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/21/2023
    Labeler - Guangdong Aimu Biological Technology Co., Ltd (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Aimu Biological Technology Co., Ltd712647107manufacture(83566-201)
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