INTENSE CARE GALACTOMYCES FIRST ESSENCE- glycerin cream 
TONYMOLY CO., LTD.

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: Glycerin 20%

INACTIVE INGREDIENT

Inactive Ingredients:
Galactomyces Ferment Filtrate, PEG/PPG-17/6 Copolymer, Butylene Glycol, Pentylene Glycol, Caprylyl Glycol, 1,2-Hexanediol, Phenoxyethanol, Chlorphenesin, Ethylhexylglycerin

PURPOSE

PURPOSE: 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 haviong problems 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

INDICATIONS AND USAGE: After washing face, at the first stage of skin care, wet cotton pad with product and lightly tap on face.

DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

INTENSE CARE GALACTOMYCES FIRST ESSENCE 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin31 mg  in 155 mL
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Pentylene Glycol (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-003-01155 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2013
Labeler - TONYMOLY CO., LTD. (688216798)
Registrant - TONYMOLY CO., LTD. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO., LTD.688216798manufacture(59078-003)

Revised: 7/2013
Document Id: cff39e8b-0dd4-4a8f-b12c-6c6d2bb4ec2e
Set id: bfd0b32d-68d3-4226-835e-a468f5c12922
Version: 1
Effective Time: 20130713
 
TONYMOLY CO., LTD.