Manugel 85
FDA Label NDC 62169-202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Anios for the product Manugel 85 (NDC 62169-202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications & usage, otc - active ingredient, microbiology, instructions for use, dosage & administration, warnings and precautions, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

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