WETTRUST GOLD (GLYCERIN) GEL [WETTRUST KOREA CO., LTD]

WETTRUST GOLD (GLYCERIN) GEL [WETTRUST KOREA CO., LTD]
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NDC 59543-1001-1, 59543-1001-2, 59543-1001-3
Set ID 7e773940-8750-4d4b-8e45-53bbb0e68234
Category HUMAN OTC DRUG LABEL
Packager WeTTrust Korea Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, butylene glycol, hydroxyethyl cellulose, sodium lactate, lactic acid, peg-14m, aloe barbadensis leaf juice, green tea extract, chamolillaRecutitalFlower extract, mulberry root extract, gingko leaf extract, natto gum, disodium edta, methylparaben, phenoxyethanol


  • PURPOSE

    supplying moisture to the dry and rough vagina


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    wash hands before opening the package
    apply a suitable amount, massage and rinse it well


  • WARNINGS

    - stop using the product and consult with a dermatologist or gynecologist if any of the following signs or symptoms appears

      rash, swelling, itching and irritation during its use
      in case any sign or symptom above appears on the applied area with the direct sunlight


    - do not use in the area, such as, of wound, eczema and dermatitis


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    WETTRUST GOLD 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59543-1001
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin0.17 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59543-1001-330 in 1 PACKAGE
    1NDC:59543-1001-210 in 1 PACKAGE
    1NDC:59543-1001-11.7 g in 1 SYRINGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/29/2013
    Labeler - WeTTrust Korea Co., Ltd (688205254)
    Registrant - WeTTrust Korea Co., Ltd (688205254)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.I.T. Co., Ltd690081646manufacture(59543-1001)

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