Label: INTENSE CARE GALACTOMYCES FIRST ESSENCE- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated July 13, 2013

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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

  • INGREDIENTS AND APPEARANCE
    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)
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