Label: XIMONTH AGARWOOD SLEEPING ESSENTIAL OIL- glycerin oil

  • NDC Code(s): 84744-065-01
  • Packager: Guangdong Ouhoe Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2024

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  • ACTIVE INGREDIENTS

    LAVENDER OIL、ROSA X DAMASCENA FLOWER OIL、TOCOPHEROL

  • PURPOSE

    Gentle and comfortable to promote sleep; relax before bedtime; easily help you fall asleep peacefully

  • USE

    Before going to bed, roll the essential oil roller evenly on the body skin and gently massage for 3-5 minutes until absorbed.

  • 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.

  • STOP USE

    Discontinue use if signs of irritation or rash occur.

  • DO NOT 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

    Store in a cool and dry place.

  • INACTIVE INGREDIENT

    GLYCERIN、ALLANTOIN

  • INDICATIONS & USAGE

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    XIMONTH AGARWOOD SLEEPING ESSENTIAL OIL 
    glycerin oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84744-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8) (LAVENDER OIL - UNII:ZBP1YXW0H8) LAVENDER OIL3 mg  in 10 mg
    ROSA X DAMASCENA FLOWER OIL (UNII: 18920M3T13) (ROSA X DAMASCENA FLOWER OIL - UNII:18920M3T13) ROSA X DAMASCENA FLOWER OIL1 mg  in 10 mg
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL1.5 mg  in 10 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z) 3 mg  in 10 mg
    GLYCERIN (UNII: PDC6A3C0OX) 1.5 mg  in 10 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84744-065-0110 mg in 1 BOX; Type 0: Not a Combination Product10/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01410/24/2024
    Labeler - Guangdong Ouhoe Biotechnology Co., Ltd. (843651433)
    Registrant - Guangdong Ouhoe Biotechnology Co., Ltd. (843651433)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Ouhoe Biotechnology Co., Ltd.843651433manufacture(84744-065)