YouGreen F by Dong Sung Bio Pharm. Co., Ltd. / Dong Sung World Wide USA, Inc. / DONG SUNG BIO PHARM.CO.,LTD._Asan Factory 42361-043 Drug Facts

YouGreen F by

Drug Labeling and Warnings

YouGreen F by is a Otc medication manufactured, distributed, or labeled by Dong Sung Bio Pharm. Co., Ltd., Dong Sung World Wide USA, Inc., DONG SUNG BIO PHARM.CO.,LTD._Asan Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

YOUGREEN F- urea ointment 
Dong Sung Bio Pharm. Co., Ltd.

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.

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42361-043 Drug Facts

Active Ingredient

Urea (25%)

Keratolytic

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.

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

Terribly dry, rough and damaged foot and the feel.

YouGreen F Oint.

25% urea

ygf carton image

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)

Revised: 6/2019
 
Dong Sung Bio Pharm. Co., Ltd.