YOUGREEN F (UREA) OINTMENT [DONG SUNG PHARM. CO., LTD.]

YOUGREEN F (UREA) OINTMENT [DONG SUNG PHARM. CO., LTD.]
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NDC 42361-043-02, 42361-043-03
Set ID 1cd82c67-e0ca-416c-9765-34d81b97c575
Category HUMAN OTC DRUG LABEL
Packager Dong Sung Bio Pharm. Co., Ltd.
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient

    Urea (25%)

  • PURPOSE

    Keratolytic

  • WARNINGS

    For external use only. When using this product

    1. The product should not be used on:

    1) Mucous membrane, including eye and lip areas.

    2) People who are allergic to the listed ingredients.

    3) People with eczema acutum or inflammatory skin diseases.

    4) People who suffer from chronic renal insufficiency.

    2. Ask a doctor before use:

    1) If you are suffering from inflammatory skin diseases and skin fissures (using this product may induce temporary reaction).

    2) If you have hypersensitive skin (using this product may induce temporary reaction).

    3. Side effects:

    1) You may experience skin irritation, burning, redness, dryness, pain, and rash when you use the product for the first time. Seek medical help if you have any doubts.

    2) You may experience skin eczematization, skin fissures, papule, stinging, burning and, rarely, edema and dryness. Stop using the product immediately. If symptoms persist, consult your doctor.

    4. Using this product may increase dermal absorption and penetration of the following ingredients: corticoid, dithranol, fluorouracil (5-FU) and alike.

    5. Precautions in application:

    1) For external use only.

    2) Do not directly apply on ulcers, macerations, cuts or infected areas.

    3) Be careful not to get product into your eyes. If any product gets into your eyes, flush immediately with a large amount of lukewarm water for at least 15 minutes and seek medical attention (Do not rub your eyes or arbitrarily apply medications).

    6. Precaution in storage: Store at room temperature, away from direct sunlight. Always recap after use.

    Keep this and all drugs out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    With high concentration of urea and skin protectants, YouGreen-F ointment effectively moisturizes and revitalizes rough and dry skins on hands, elbows, knees and heels, leaving your skin soft and smooth. Especially, 25% urea provides rich hydration, helping your skin to retain moisture for long-lasting suppleness.

  • Direction

    After washing affected area, apply appropriate amount to dry skin and gently massage for better absorption. Use as often as needed.

  • Inactive Ingredients

    Ceresin, Cetanol, White Petrolatum, Squalane, Light Liquid Paraffin, Cetyl Palmitate, Dimethicone, Sodium Cetyl Sulfate, Yeast Extract, Ethyl Ascorbyl Ether, Panthenol, Polysorbate 60, Glycerylstearate/PEG-100 Stearate, Tocopherol Acetate, Sodium hydroxide, Butylene Glycol, Disodium Edetate, Pyridoxine Hydrochloride, Ammonium Glycyrrhizinate, Methylparaben, Propylparaben, Fragrance, Water

  • PRINCIPAL DISPLAY PANEL

    Terribly dry, rough and damaged foot and the feel.

    YouGreen F Oint.

    25% urea

    ygf carton image

  • INGREDIENTS AND APPEARANCE
    YOUGREEN F 
    urea ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42361-043
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA7.5 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SQUALANE (UNII: GW89575KF9)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CETYL SULFATE (UNII: 3V3Y3O7BIQ)  
    YEAST (UNII: 3NY3SM6B8U)  
    3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42361-043-021 in 1 CARTON12/21/201712/31/2019
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:42361-043-031 in 1 CARTON12/21/201712/31/2019
    260 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/21/201712/31/2019
    Labeler - Dong Sung Bio Pharm. Co., Ltd. (687811661)
    Registrant - Dong Sung World Wide USA, Inc. (784969219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dong Sung Bio Pharm. Co., Ltd.687811661label(42361-043)

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