Label: INCLEAR- glycerin gel

  • 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 July 29, 2013

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  • ACTIVE INGREDIENT

    glycerin

  • INACTIVE INGREDIENT

    water, butylene glycol, sodium lactate, hydroxyethyl cellulose, lactic acid, sophora extract, licorice extract, methylparaben, disodium edta, chlorhexidine Digluconate


  • PURPOSE

    cleansing external genital and revoving odor (keep vagina fresh and clean)


  • 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
    INCLEAR 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59543-2001
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin0.04 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)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59543-2001-330 in 1 PACKAGE
    1NDC:59543-2001-210 in 1 PACKAGE
    1NDC:59543-2001-11.7 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(59543-2001)
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