Label: METABOLIC BRIGHTENING TONE UP- adenosine, alpha bisabolol cream

  • 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 December 30, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Adenosine 0.04%
    .ALPHA.-BISABOLOL, (+/-)- 0.5%

  • PURPOSE

    Anti wrinkle, Skin Brightening

  • Uses

    Multi-cream, which can help to have a whitening effect and works as a makeup base, maintains a bright and clear skin tone.

  • Warnings

    For external use only.
    In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Use this product as the last step in your skincare routine or as the first step in your makeup routine.
    Apply an appropriate amount evenly with fingertips.

  • Other Information

    Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

  • Questions

    www.rootsallo.com 82-31-429-0588

  • Inactive ingredients

    Water, Dicaprylyl Carbonate, Persea Gratissima (Avocado) Oil, Propanediol, Polyglyceryl-3 Polyricinoleate, Caprylic/Capric Triglyceride, Sorbitan Olivate, Titanium Dioxide, Hydrogenated Olive Oil, Butyrospermum Parkii (Shea) Butter, Sodium Chloride, Olea Europaea (Olive) Fruit Oil, Glycerin, Glyceryl Caprylate, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Oil, Glycyrrhiza Inflata Root Extract, Ultramarines, Magnesium Stearate, Olea Europaea (Olive) Oil Unsaponifiables, Tocopherol, Lauroyl Lysine, Paeonia Suffruticosa Root Extract, Mica, Aluminum Hydroxide, Arginine, Sodium Hyaluronate, p-Anisic Acid, Beta-Glucan, *Limonene (essential oil component)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    METABOLIC BRIGHTENING TONE UP 
    adenosine, alpha bisabolol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.04 g  in 100 mL
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) (.ALPHA.-BISABOLOL, (+/-)- - UNII:36HQN158VC) .ALPHA.-BISABOLOL, (+/-)-0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82450-030-021 in 1 CARTON12/01/2021
    1NDC:82450-030-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2021
    Labeler - rootsallo Qwell (695495466)
    Registrant - rootsallo Qwell (695495466)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elan Cosmetic Co.,ltd688204926manufacture(82450-030)