Label: HAESUM MARINE FILL SOFTNER- glycerin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 18, 2015

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    water, butylene glycol, sea water, hydrolyzed hyaluronic acid, algae ext, collagen, etc.

  • PURPOSE

    skin protectant



  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    after cleansing your face and apply


  • WARNINGS

    -If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    -This product is for exeternal use only. Do not use for internal use
    -If possible, avoid direct sunlight and store in cool and area of low humidity
    -In order to maintain the quality of the product and avoid misuse
    -Avoid placing the product near fire and store out in reach of children


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    HAESUM MARINE FILL SOFTNER 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69327-0101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69327-0101-170 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/25/2014
    Labeler - Beauty Line Co., Ltd. (688528938)
    Registrant - Beauty Line Co., Ltd. (688528938)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biocostech Co., Ltd.690407325manufacture(69327-0101)
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