Label: WELLAGE POST PROCEDURE- 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 November 1, 2014

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    water, cyclopentasiloxane, zinc oxide, titanium dioxide, arbutin, dimethicone, talc, sodium chloride, etc


  • PURPOSE

    anti wrinkle
    whitening
    sun block


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    ake a proper amount and apply on the face evenly

  • WARNINGS

    Do not use in the following cases(Eczema and scalp wounds)
    Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult ypur phamacisr or doctor
    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
    Storage and handling precautions
    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
    WELLAGE POST PROCEDURE 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69346-1001
    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
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ADENOSINE (UNII: K72T3FS567)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69346-1001-140 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2014
    Labeler - HUGEL PHARMA CO.,LTD. (688400184)
    Registrant - HUGEL PHARMA CO.,LTD. (688400184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanacos Co., Ltd.690177857manufacture(69346-1001)
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