Label: MANUGEL 85- ethanol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 31, 2014

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    Thixotropic hydroalcoholic gel for hygienic treatment and surgical disinfetion by hand-rubbing.

    Ethanol (700 mg/g ie 755 ml/l - N° CAS 64-17-5) in the presence of thickening, moisturizing and emollient agents, and water.  Without purfume nor coloring.

  • MICROBIOLOGY

    Bactericidal: EN 1040, pr EN 12054, EN 1500, EN 12791.  Tuberculocidal: EN 14348.  Yeasticidal EN 1275, EN 1650.  Virucidal: EN 14476+A1 (30 sec.).  Active against HIV-1, PRV (surrogate of HBV), BVDV (surrogate of HCV), Rotavirus, Herpes virus, Coronavirus, Norovirus, Influenza virus A [H1N1] and Influenca virus A NIBRG14 [H5N1].

  • INSTRUCTIONS FOR USE

    A ready-to-use gel.  Hygienic treatment: 3 ml* for a hand-rubbing time of 30 seconds.  Surgical disinfection: 2 x 3 ml* for a hand-rubbing time of two times 45 seconds.  Well-apply and rub until complete dry.  Do not rinse.  (*3 ml = 2 pump squirts).  For application in operating theater and frequency of use, refer to the protocol of the establishment.

    Hygienic treatment: 3 ml* for a hand-rubbing time of 30 seconds. Surgical disinfection: 2 x 3 ml* for a hand-rubbing time of two times 45 seconds. Well-apply and rub until complete dry. Do not rinse. (*3 ml = 2 pump squirts).

  • WARNINGS AND PRECAUTIONS

    Topical route exclusively. Flammable. Keep away from sources of ignition - no smoking. Avoid contact with eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. If swallowed, seek medical advice immediately and show this container or label. If necessary, contact the poison control center. Keep out of reach of children. Do not dispose of product directly into the environment. Do not reuse the packaging. This material and the container must be disposed of in a safe way. Use of the product in accordance with the use instructions does not alter the requirements in terms of air extraction volume. Storage: from +5°C to +25°C. Human hygiene biocidal product (Main Group 1 - PT1 - directive 98/8/EC). Professional use. Made in France.

    Keep out of reach of children.

  • PURPOSE

    Thixotropic hydroalcoholic gel for hygienic treatment and surgical disinfetion by hand-rubbing

  • INACTIVE INGREDIENT

    Active ingredient in the presence of thickening, moisturizing and emollient agents, and water. Without purfume nor coloring.

  • WARNINGS

    Topical route exclusively. Flammable. Keep away from sources of ignition - no smoking. Avoid contact with eyes. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. If swallowed, seek medical advice immediately and show this container or label. If necessary, contact the poison control center. Keep out of reach of children. Do not dispose of product directly into the environment. Do not reuse the packaging. This material and the container must be disposed of in a safe way. Use of the product in accordance with the use instructions does not alter the requirements in terms of air extraction volume. Storage: from +5°C to +25°C. Human hygiene biocidal product (Main Group 1 - PT1 - directive 98/8/EC). Professional use. Made in France.

  • PRINCIPAL DISPLAY PANEL


    manugelfront

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MANUGEL 85 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62169-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL400 mL  in 500 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.3 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX) 99.7 mL  in 500 mL
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62169-202-1212 in 1 PACKAGE
    1NDC:62169-202-17500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2014
    Labeler - Laboratoires Anios (274758465)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Anios274758465manufacture(62169-202)