Label: RED GINSENG PURE RED LIVELY WATER- allantoin cream

  • NDC Code(s): 52123-030-01
  • Packager: SOBAEK INSAM FARMING COOPERATIVE CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

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

  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

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  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Red Ginseng Extract, Chamaecyparis Obtusa Water, Butylene Glycol, Glycerine, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone Crosspolymer, Niacinamide, Sodium Hyaluronate, Sodium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone/PEG-10/15 Crosspolymer , Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract , Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Origanum Vulgare Leaf Extract, Portulaca Oleracea Extract, Chamaecyparis Obtusa Leaf Extract, Cinnamomum Cassia Bark Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hydrolyzed Collagen, Arbutin, Adenosine, Disodium EDTA, Fragrance

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  • PURPOSE

    Purpose: Skin Protectant

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  • WARNINGS

    Warnings:
    1. Discontinue use cosmetics when the problems occur as follow.
    If you keep using cosmetics, the problems become worse. Please consult with a skin specialist.
    1) While using, if red spots, swellings itching and irritation etc occur.
    2) When the above symptom occurs in the applied area caused by direct sunlight.
    2. Do not use cosmetics on the wound or on the problem area such as eczema and dermatitis etc.
    3. Storage and handling cautions
    1) Be sure to cover the top after using it.
    2) Keep out of reach of children
    3) Do not keep it in the place under high or low temperature and in direct sunlight.
    4) Do not take the content. (Specially infant and children etc) when the content was swallowed in the mouth, wash it immediately and consult a medical specialist if any problems occur.
    5) If you put the content taken out of the container back, it may be spoil

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS AND USAGE

    Indication and usage:
    Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

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  • DOSAGE AND ADMINISTRATION

    Dosage and administration:
    Everyday, Apply toner first after washing face, take a moderate amount of Pure Red Lively Water and they apply slowly to be absorbed.

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    RED GINSENG PURE RED LIVELY WATER 
    allantoin cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52123-030
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Allantoin (ALLANTOIN) Allantoin 0.25 g  in 50 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Butylene Glycol  
    Glycerin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52123-030-01 50 g in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 10/01/2012
    Labeler - SOBAEK INSAM FARMING COOPERATIVE CORPORATION (631133568)
    Registrant - SOBAEK INSAM FARMING COOPERATIVE CORPORATION (631133568)
    Establishment
    Name Address ID/FEI Business Operations
    SOBAEK INSAM FARMING COOPERATIVE CORPORATION 631133568 manufacture(52123-030)
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