MANUGEL 85- ethanol gel 
Laboratoires Anios

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.

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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.

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].

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).

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.

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

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

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.


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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)

Revised: 3/2014
Document Id: 35842aa1-812f-42c1-a7bf-3a40e58ddfee
Set id: 5b980767-7a5a-4674-96c5-78cf206cd463
Version: 3
Effective Time: 20140331
 
Laboratoires Anios