Label: CELL POWER BOOSTING ESSENCE- allantoin 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 March 20, 2017

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  • ACTIVE INGREDIENT

    Allantoin (0.01%) - Skin Protectact
    Pyridoxine HCl (0.001%) - Skin Protectact

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  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Sodium Hyaluronate, Niacinamide, Propylene Glycol, Polyglutamic acid, Methionine, Serine, Histidine, 1,2-Hexandiol, Hydroxyethylethylcelluose, Calcium Pantothenate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Maltodextrin / Sodium Starch Octenylsuccinate, Camellia Sinensis Leaf Extract, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavendula Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Alcohol, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (matricaria) Flower Extract, Portulaca Oleracea Extract, Belamcanda Chinensis Root Extract, Glycerin, Betaine, Octanediol, Citrus grandis (grapefruit) seed extract, Artemisia princeps extract, Xanthan Gum, PEG-60 Hydrogenated Castor Oil, Carbomer, Triethanolamine, Dipotassium Glycyrrhizate, Vanillyl butyl ether, Adenosine, Ethylhexylglycerin, Disodium EDTA

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  • PURPOSE

    Skin Protectact

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  • WARNINGS

    For skin use only.
    Do not use
     on puncture wounds  on animal bites  on serious burns  on area with scratches, eczema, or dermatitis
    When using this product
     avoid contact with eyes
    Stop use and ask a doctor if
     you have allergy or skin disease
     rash or irritation develops and lasts
     red spots, swelling, itching, irritation and other abnormalities develops

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  • KEEP OUT OF REACH OF CHILDREN

     if swallowed, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

     Clean skin thorounghly before using
     After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
     Use it every days in the evening according to skin condition

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  • DOSAGE & ADMINISTRATION

     Clean skin thorounghly before using
     After cleansing, apply toner and press lightly. Then, apply a moisturizing cream
     Use it every days in the evening according to skin condition

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    CELL POWER BOOSTING ESSENCE 
    allantoin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71327-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.000021 g  in 210 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 0.0000021 g  in 210 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Methionine (UNII: AE28F7PNPL)  
    Serine (UNII: 452VLY9402)  
    Histidine (UNII: 4QD397987E)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    PEG-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
    Adenosine (UNII: K72T3FS567)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71327-002-01 210 mL in 1 PACKAGE; Type 0: Not a Combination Product 03/20/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/20/2017
    Labeler - MICELL KOREA CO.,LTD (689851542)
    Registrant - MICELL KOREA CO.,LTD (689851542)
    Establishment
    Name Address ID/FEI Business Operations
    MICELL KOREA CO.,LTD 689851542 manufacture(71327-002)
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