Label: TEN TEN CELL- glycerin solution

  • 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 September 15, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 2%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Adipose stem cell media, Hydrogenated Lecithin, 1,2-Hexanediol, Arbutin, Butylene Glycol, Dipropylene Glycol, Sodium Hyaluronate, Red Ginseng Extract, Platycodon Grandiflorum Root Extract, Bupleurum Chinensis Root Extract, Panax Ginseng Root Extract, Dioscorea Japonica Root Extract, Zizyphus Jujuba Fruit Extract, Atractyloides Japonica Rhizome Extract, Forsythia Suspensa Fruit Extract, Cnidium Officinale Root Extract, Scutellaria Baicalensis Root Extract, Schizonepeta Tenuifolia Extract, Morus Alba Bark Extract, Gardenia Florida Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Angelica Dahurica Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Citrus Unshiu Peel Extract, Poria Cocos Extract, Angelica Gigas Root Extract, Paeonia Albiflora Root Extract, Astragalus Membranaceus Root Extract, rh-Oligopeptide-1, rh-Polypeptide-1, rh-Polypeptide-2, rh-Polypeptide-9, Octapeptide-7, Acetyl Hexapeptide-8, Copper Tripeptide-1, Nicotinoyl Tripeptide-1, Solanum Lycopersicum (Tomato) Callus Culture Extract, Caprylhydroxamic Acid, Polysorbate 80, Caprylyl Glycol, Allantoin, Triethanolamine, Carbomer, Xanthan Gum, Adenosine

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. Please stop using when you have trouble as below. Consult to dermatologists when it gets worse. A, skin has red spot, swollen or itchiness and sensational skin B. Skin has those symptoms by direct sunlight.

    2. Do not use wounds, eczema, dermatitis

    3. Precautions A. Must keep closing lid after using. B. Keep out of children C. Do not keep in high or low temperatures and avoid direct sunlight

    4. Similar products with same components (More than 2% of arbutin) are reported in “Human applicable test data” as an example of papule and mild itching.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children.

  • INDICATIONS & USAGE

    Indications & Usage: After washing the face, dispense an appropriate amount into your palm, and evenly apply to the entire face.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TEN TEN CELL 
    glycerin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70087-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin0.12 mg  in 10 
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Arbutin (UNII: C5INA23HXF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70087-010-0110 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2015
    Labeler - MARIA BIOTECH CO., LTD. (688377779)
    Registrant - MARIA BIOTECH CO., LTD. (688377779)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARIA BIOTECH CO., LTD.688377779manufacture(70087-010)