Drug Labeling and Warnings

Drug Details [pdf]

PURE RED RED GINSENG CLEANSING- allantoin aerosol, foam 
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: Allantoin 0.50%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Stearic Acid, Lauric Acid, Glycerin, Myristic Acid, Potassium Hydroxide, Glyceryl Stearate, PEG-100 Stearate, Beeswax, Lauramide DEA,
Cocamidopropyl Betaine, Red Ginseng Extract, Hydroxyethylcellulose, Chlorphenesin, Dimethicone, Disodium EDTA, Hamamelis Virginiana (Witch Hazel) Extract, Fragrance

PURPOSE

Purpose: Skin Cleanser, Skin Protectant

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Replace the cap after use.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

-Makes the skin clear

-Removes the dusty and waste from the skin

Directions

Directions:

While washing your face, take an enough amount and use lukewarm water to make sufficient amount of foam. Rub your face like you are massaging and then wash it off with lukewarm water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PURE RED RED GINSENG CLEANSING 
allantoin aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52123-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Stearic Acid (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52123-050-02	1 in 1 PACKAGE	11/01/2018	01/02/2019
1	NDC: 52123-050-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2018	01/02/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA		631133568	manufacture(52123-050)

Revised: 9/2019

Document Id: cb5a93a7-1631-4964-910e-69ecf7161eeb

34390-5

Set id: f23cd4fd-ee85-4382-a765-43c7759a05b0

Version: 2

Effective Time: 20190905

 

SOBAE