NEOXIDINA ALCOLICA INCOLORE 250 ML.

Surgical Medical Device, Intact Skin (Chlorhexidine gluconate)
Ready-to-use hydroalcoholic solution (EXTERNAL USE)

Composition
100 g of solution contain:
Active ingredients:
Chlorhexidine gluconate 0.50g
Ethyl alcohol: 66.29g

Excipients:
Glycerin (F.U.): 0.50g
Myristyl alcohol: 1.50g
Alcohol denaturants, purified water q.s. to: 100.00g

Product Presentation (chemical - physical characteristics)
Neoxidina Alcolica Incolore is a ready-to-use alcoholic solution for the antisepsis of intact skin and hands.
It contains chlorhexidine digluconate and ethyl alcohol.
It has excellent skin tolerability; even after prolonged use, hands remain soft and smooth, thanks to the presence of particular emollient and superfatting substances (glycerin and myristyl alcohol), which prevent epidermal cracking, promote the regeneration of the lipid component of the skin, and restore physiological pH.
It has an immediate and prolonged action over time.
The recent guidelines of the American CDC suggest the use of alcohol solutions for social and surgical antisepsis of the hands, as their use, unlike antiseptic soaps, does not require water, and is easy and quick.
With the addition of emollients, these alcohol solutions show greater skin tolerability compared to antiseptic liquid soaps in which the use of dermoprotective ingredients has little effectiveness.

Toxicological data related to chlorhexidine are reported below:
• Acute chlorhexidine toxicity
Acute toxicity studies after oral, intravenous and subcutaneous administration were conducted on rats and mice. The results obtained are summarized as follows:
• oral route: 1260-1950 mg/kg
• subcutaneous route: 637-632 mg/kg
• intravenous route: 18-13 mg/kg
• Chronic chlorhexidine toxicity
In rats, chronic oral exposure for 2 years to chlorhexidine solutions at doses of 5, 25 and 40 mg/kg/day showed that chlorhexidine is not carcinogenic.
In these animals, reactive histiocytosis of the mesenteric lymph nodes was observed: this phenomenon, however, did not have a progressive character during the two years of observation and showed regression upon discontinuation of treatment.

Chemical-physical characteristics of Neoxidina Alcolica Incolore:
Appearance: Clear solution;
Color: Colorless;
Specific gravity:
Unit of measure: g/ml at 20 °C;
Standard values: 0.865 - 0.885;
Chlorhexidine assay:
Unit of measure: % w/w;
Standard values: 0.48 – 0.52.

Field and method of use
Neoxidina Alcolica Incolore is very practical to use as it does not require the addition of water for washing or rinsing; skin and hand antisepsis can, therefore, be carried out anywhere, regardless of the presence of sponges and water.
Neoxidina Alcolica Incolore can be used in all departments where hygiene is important, such as hospital wards, operating rooms, intensive care units, ambulances, diagnostic clinics, and others, i.e., for antisepsis:

a) of the patient's intact skin before surgical interventions or other invasive maneuvers;
b) of the hands of healthcare personnel for the implementation of antiseptic procedures, after contact with infected materials and in surgical preparation.
The product should be used as is, without dilution.
a)Antisepsis of the patient's intact skin: impregnate a sterile swab and pass it over the area to be treated, rubbing vigorously for at least two minutes.
b) Pre-surgical hand antisepsis:
• dispense 6 ml (3 strokes of the 2 cc dispenser pump) of solution onto hands and forearms;
• rub vigorously for at least 3 minutes or until completely dry;
• repeat the operation a second time.
c) Hand antisepsis for healthcare personnel in the ward:
• dispense and spread 4 ml (2 strokes of the 2 cc dispenser pump) of solution onto hands and wrists;
• rub vigorously for at least 30 seconds and wait until completely dry;

It should be emphasized that, before starting hand antisepsis operations, or later when hands are visibly dirty, it is necessary to wash them with an antiseptic detergent solution.

Mechanism of action and germicidal activity:
Neoxidina Alcolica Incolore is a solution based on chlorhexidine digluconate and ethyl alcohol.
Chlorhexidine gluconate is particularly active against Gram-positive germs, yeasts, and viruses.

The action is attributable to an inactivation of the fundamental enzymatic systems of the cell wall, initial disorganization of the cytoplasmic membrane, modification of permeability, and consequent loss of cellular material.
Ethyl alcohol has excellent in vitro germicidal activity against Gram-positive and Gram-negative bacteria, including drug-resistant pathogens (e.g., MRSA and VRE), mycobacteria, and yeasts.
The rapid biocidal action is attributable to its ability to denature, in the presence of water, the proteins of the cytoplasmic membrane.
As demonstrated by specific biocidal activity studies, Neoxidina Alcolica Incolore effectively reduces the resident and transient bacterial flora of the skin.
The solution has bactericidal (Gram + and Gram - bacteria), fungicidal (Candida albicans), and virucidal activity.

The biocidal efficacy data of the product Neoxidina Alcolica Incolore are summarized in the following tables.

Table 2: Basic bactericidal activity (EN 1040: 1997) - Contact time = 30 seconds

Microorganism group: Gram + bacteria
Specific strain: Staphylococcus aureus ATCC 6538
Reduction: > 10⁵

Microorganism group: Gram - bacteria
Specific strain: Pseudomonas aeruginosa ATCC 15442
Reduction: > 10⁵

Microorganism group: Acid-resistant bacilli
Specific strain: Mycobacterium terrae ATCC 15755
Reduction: > 10⁵

Table 3: Bactericidal activity in suspension for hygienic and surgical hand rubbing (prEN 12054: 1995)
- Contact time = 30 seconds

Microorganism group: Gram + bacteria
Specific strain:
Enterococcus hirae ATCC 10541
Reduction: > 10⁴

Staphylococcus aureus ATCC 6538
Reduction: > 10⁴

Microorganism group: Gram - bacteria
Specific strain:
Escherichia coli K12 NCTC 10538
Reduction: > 10⁴
Pseudomonas aeruginosa ATCC 15442
Reduction: > 10⁴

Bactericidal activity under simulated practical conditions of use (EN 1500: 2000) - Contact time = 30 seconds
Microorganism group: Gram - bacteria
Specific strain: Escherichia coli K12 NCTC 10538
Average logarithmic reduction: 3.96

Basic fungicidal activity (EN 1275: 1999) - Contact time = 30 seconds
Microorganism group: Yeasts
Specific strain: Candida albicans ATCC 10231
Reduction: > 10⁴

Virucidal activity - Contact time = 30 seconds
Virus tested: HBV
Test type: MADT test
Reduction: > 10³

Virus tested: HCV
Test type: Inhibition of viral binding to VERO cells
Reduction: > 10³

Virus tested: HIV
Test type: Inhibition of infectivity on sensitive cells
Reduction: > 10⁴

Furthermore, the product has been tested, according to the protocol defined by standard prEN 14476:
2002, against a strain of Rotavirus.
The results obtained demonstrate that Neoxidina Alcolica Incolore is effective against this specific viral strain in 30 seconds under clean conditions, and in 1 minute under dirty conditions.

All primary packaging is manufactured from high-density polyethylene (HDPE) according to the technical specifications provided by the European Pharmacopoeia.
This material does not contain latex and is perfectly compatible with all components of the formulation.