FDA Label for Manugel 85
View Indications, Usage & Precautions
Manugel 85 Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires Anios. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage
Thixotropic hydroalcoholic gel for hygienic treatment and surgical disinfetion by hand-rubbing.
Otc - Active Ingredient
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.
Dosage & Administration
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - 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.
Package Label.Principal Display Panel
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