Label: BOOSTING APPLE SOOTHING WASH OFF- pyrus malus fruit extract gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 1, 2023

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  • ACTIVE INGREDIENT

    pyrus malus fruit extract

  • INACTIVE INGREDIENT

    glycerin, butylene glycol, etc.

  • PURPOSE

    skin vitality, skin glow

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • WARNINGS

    This product is for exeternal use only. Do not use for internal use
    Storage and handling precautions
    If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse
    Avoid placing the product near fire and store out in reach of children

    - consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

    - do not use on wounded area

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BOOSTING APPLE SOOTHING WASH OFF 
    pyrus malus fruit extract gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71217-0062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APPLE FRUIT OIL (UNII: 9NT987I3A8) (APPLE FRUIT OIL - UNII:9NT987I3A8) APPLE FRUIT OIL58.69 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71217-0062-180 mL in 1 JAR; Type 0: Not a Combination Product02/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2023
    Labeler - inthismorning co ltd (695126076)
    Registrant - inthismorning co ltd (695126076)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENS KOREA Co., Ltd.688223124manufacture(71217-0062)
    Establishment
    NameAddressID/FEIBusiness Operations
    inthismorning co ltd695126076label(71217-0062)