Label: FIKIA MARINE VELVET WHITENING- glycerin cream

  • 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 October 25, 2014

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  • ACTIVE INGREDIENT

    glycerine


  • INACTIVE INGREDIENT

    water, butylene glycol, sodium hyaluronate, cetyl ethylhexanoate, niacinamide, cetearyl alcohol, etc


  • PURPOSE

    skin whitening
    anti-wrinkle


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    apply a moderate amount evenly after brightening serum


  • 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
    FIKIA MARINE VELVET WHITENING 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69327-5001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 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:69327-5001-150 mL in 1 BOTTLE
    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(69327-5001)
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