MANUGEL 85 by Laboratoires Anios MANUGEL 85- ethanol gel

MANUGEL 85 by

Drug Labeling and Warnings

MANUGEL 85 by is a Otc medication manufactured, distributed, or labeled by Laboratoires Anios. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MANUGEL 85 
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62169-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	400 mL  in 500 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T)	PHENOXYETHANOL	0.3 g  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)	99.7 mL  in 500 mL

Product Characteristics
Color		Score
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62169-202-12	12 in 1 PACKAGE
1	NDC: 62169-202-17	500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2014

Labeler - Laboratoires Anios (274758465)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Anios		274758465	manufacture(62169-202)