WELLAGE POST PROCEDURE POINT CONCEALER (TITANIUM DIOXIDE) CREAM [HUGEL PHARMA CO.,LTD]

WELLAGE POST PROCEDURE POINT CONCEALER (TITANIUM DIOXIDE) CREAM [HUGEL PHARMA CO.,LTD]
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NDC 69346-4001-1
Set ID b2045369-f109-43d6-981e-c3998960f6a1
Category HUMAN OTC DRUG LABEL
Packager HUGEL PHARMA CO.,LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    titanium dioxide


  • INACTIVE INGREDIENT

    isopropyl myristate, mica candelilla wax, sorbitan olivate ceresin, dimethicone, lanolin, methicone, etc


  • PURPOSE

    sun block, skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・If the product gets into the eyes, don't rub but rinse with water.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    WELLAGE POST PROCEDURE POINT CONCEALER 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69346-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69346-4001-14.8 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2014
    Labeler - HUGEL PHARMA CO.,LTD (688400184)
    Registrant - HUGEL PHARMA CO.,LTD (688400184)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUGEL PHARMA CO.,LTD688400184manufacture(69346-4001)

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