RED GINSENG PURE RED LIVELY WATER- allantoin cream 
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 ingredient: Allantoin 0.5%

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

PURPOSE

Purpose: Skin Protectant

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

RED GINSENG PURE RED LIVELY WATER 
allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52123-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.25 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52123-030-0150 g in 1 CARTON; Type 0: Not a Combination Product10/01/201212/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201212/30/2017
Labeler - SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA (631133568)
Registrant - SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA (631133568)
Establishment
NameAddressID/FEIBusiness Operations
SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA631133568manufacture(52123-030)

Revised: 11/2018
 
SOBAEK INSAM FARMING ASSOCIATION-SOBAEK KOREA