Label: ORALHOE PROBIOTIC BRIGHTENING- glycerin cream

  • NDC Code(s): 84660-036-01
  • Packager: Guangdong Ximonth Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 26, 2024

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  • Active Ingredient(s)

    XYLITOL、PROPOLIS EXTRACT、MENTHA PIPERITA (PEPPERMINT)EXTRACT、CHRYSANTHELLUM INDICUM EXTRACT

  • Purpose

    1.Reduce oral odour, make breath fresh and pleasant, increase oral comfort.
    2.Effectively removes tea stains, coffee stains and other pigmentation on the surface of the teeth, making the teeth whiter and brighter.
    3. Prevents tooth decay, helps to protect the health of teeth and gums.
    4. Safe and gentle ingredients, suitable for everyone, including people with sensitive teeth.

  • Use

    1. Take an appropriate amount of toothpaste on the toothbrush
    2. Use the correct way to brush for 2-3 minutes
    3. Rinse your mouth with water

  • Warnings

    Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

  • Do not use

    Discontinue use if signs of irritation or rash occur.

  • STOP USE

    Discontinue use if signs of irritation or rash occur.

  • KEEP OUT OF REACH OF CHILDREN

    Please keep out of reach of children. Do not swallow.

  • STORAGE AND HANDLING

    Avoid freezing and excessive heat above 40C (104F) )
    Store in a cool and dry place.

  • INACTIVE INGREDIENT

    GLYCERIN

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ORALHOE PROBIOTIC BRIGHTENING 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84660-036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA X PIPERITA WHOLE - UNII:79M2M2UDA9) MENTHA X PIPERITA WHOLE18 g  in 120 g
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0) (CHRYSANTHELLUM INDICUM TOP - UNII:STJ856D1Z0) CHRYSANTHELLUM INDICUM TOP12 g  in 120 g
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL30 g  in 120 g
    PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF) PROPOLIS WAX24 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 36 g  in 120 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84660-036-01120 g in 1 BOX; Type 0: Not a Combination Product09/27/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/27/2024
    Labeler - Guangdong Ximonth Technology Co., Ltd. (699436264)
    Registrant - Guangdong Ximonth Technology Co., Ltd. (699436264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Ximonth Technology Co., Ltd.699436264manufacture(84660-036)