FEDORA CONCENTRATING HYDRO SERUM (GLYCERIN) LIQUID [FEDORA INTERNATIONAL CO., LTD.]

FEDORA CONCENTRATING HYDRO SERUM (GLYCERIN) LIQUID [FEDORA INTERNATIONAL CO., LTD.]
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NDC 62620-5001-1
Set ID 0b8b0b30-4983-4278-b8bb-1588249f7d28
Category HUMAN OTC DRUG LABEL
Packager Fedora International Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    water, niacinamide, etc.


  • PURPOSE

    anti wrinklewhiteningskin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply proper amount to the skin

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)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
    FEDORA CONCENTRATING HYDRO SERUM 
    glycerin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62620-5001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62620-5001-135 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/26/2015
    Labeler - Fedora International Co., Ltd. (689049099)
    Registrant - Fedora International Co., Ltd. (689049099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fedora International Co., Ltd.689049099manufacture(62620-5001)

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