Label: METABOLIC INTENSIVE CARE- 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, Whitening

  • Uses

    Helps to have balanced skincare with rich nutrition and deep moisturizing effects on the skin.

  • 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

    Apply an appropriate amount on the skin and pat evenly.

  • 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, Propanediol, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Isoamyl Laurate, Cetearyl Alcohol, Macadamia Integrifolia Seed Oil, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Hydrogenated Vegetable Oil, Hydrogenated Olive Oil, Cetearyl Glucoside, Stearic Acid, Palmitic Acid, Sorbitan Olivate, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Tocopherol, Scutellaria Baicalensis Root Extract, Arginine, Olea Europaea (Olive) Oil Unsaponifiables, p-Anisic Acid, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Cetyl Alcohol, Stearyl Alcohol, Citric Acid, Polygonum Cuspidatum Root Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    METABOLIC INTENSIVE CARE 
    adenosine, alpha bisabolol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-020
    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)  
    Propanediol (UNII: 5965N8W85T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82450-020-021 in 1 CARTON12/01/2021
    1NDC:82450-020-0150 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(82450-020)