Drug Details [pdf]

PURE RED GINSENG- witch hazel soap
SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: Hamamelis Virginiana (Witch Hazel) Leaf Extract 0.1%

INACTIVE INGREDIENT

Inactive ingredients:
Sekken Soji, Panax Ginseng Root Extract, Fragrance, Angelica Gigas Root Extract, Houttuynia Cordate Extract, Magnolia Liliflora Bud Extract, Artemisia Princeps Leaf Extract, Lonicera Japonica (Honeysuckle) Leaf Extract, Gardenia Florida Fruit Extract, Ulmus Davidiana Root Extract, Camellia Sinensis Leaf Extract, Vitis Vinifera (Grape) Seed Oil, Sericin, Aloe Barbadensis Leaf Extract, Chrysanthem Morifolium Flower Extract, Salicylic Acid, Alginic Acid

PURPOSE

Purpose: Skin Cleansing, Skin Protectant

WARNINGS

Warnings:
1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problem such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

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

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.

DOSAGE AND ADMINISTRATION

Dosage and administration:
Use hands to lather Facial Soap over makeup-free face and throat. Rinse with tepid water. Pat dry. Use twice daily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PURE RED GINSENG
witch hazel soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52123-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	Witch Hazel	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Salicylic Acid (UNII: O414PZ4LPZ)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 52123-020-01	100 g in 1 CARTON; Type 0: Not a Combination Product	06/01/2012	01/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/01/2012	01/02/2019

Labeler - SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA (631133568)

Registrant - SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA (631133568)

Name	Address	ID/FEI	Business Operations
Establishment
SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA		631133568	manufacture(52123-020)

Revised: 9/2019

Document Id: 30dbcfe1-8294-420f-8d78-59dd8e5185c9

Set id: dc7375e0-acb0-44c2-a59e-cc532c786399

Version: 3

Effective Time: 20190905

SOBAE

Drug Labeling and Warnings