Active substances: octenidine dihydrochloride and phenoxyethanol. 1 g of gel contains 1 mg of octenidine dihydrochloride (an antiseptic and disinfectant) and 10 mg of phenoxyethanol (a bactericidal agent).

Other ingredients are: ethanol 96%, glycerol 85%, poloxamer 407 (contains butylhydroxytoluene (E321)), and purified water.

It is used on the skin for the repeated, time-limited, supportive antiseptic treatment of minor and superficial wounds in patients of all age groups.

Do not use Octizy Gel:
· If you are allergic to octenidine dihydrochloride, phenoxyethanol, or any of the other ingredients of this medicine.
· This medicine must not be used for rinsing the abdominal cavity (e.g., during surgery [intraoperative]), the urinary bladder, or the eardrum.

Warnings and precautions:
Talk to your doctor, pharmacist, or nurse before using Octizy Gel.

Do not use more of the medicine than necessary, do not swallow it, and do not allow it to enter the bloodstream, e.g., through accidental injection.
To avoid possible tissue damage, care must be taken during use to ensure that the product is not applied under pressure or injected into tissue.
In the case of cavity wounds (larger, deeper wounds with loss of subcutaneous tissue), adequate drainage of wound fluid must be ensured (for example, by drainage or special wound treatment techniques /so-called skin flap/).
Do not use Octizy Gel in the eyes. In case of contact with the eyes, rinse immediately with plenty of water.

Children and adolescents:

Use with caution in newborns, especially in premature infants. Octizy Gel may cause serious skin damage. Remove any excess product and ensure that the gel does not remain on the skin longer than necessary (including gel-soaked materials in direct contact with the patient).
In children under 6 years of age, the use of Octizy Gel should be limited to a few days.
Due to its topical use, Octizy Gel is used in the same way in adults, children, and adolescents.

Other medicines and Octizy Gel:
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Do not use this medicine together with povidone-iodine–based skin disinfectants on adjacent skin areas, as this may cause intense brown or purple discoloration of the skin.
Do not use Octizy Gel together with anionic surfactants (for example, soap, detergents, or cleaning agents), as this may reduce or eliminate the antimicrobial effectiveness of this medicine.

Pregnancy: Octizy Gel must not be used during pregnancy.
Breastfeeding: It is unlikely that this medicine passes into breast milk. During breastfeeding, Octizi Gel must not be used in the breast area.

Driving and using machines: It has no or negligible influence on the ability to drive and use machines.

Contains:

Alcohol (ethanol) and butylhydroxytoluene; butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
95.2 mg alcohol (ethanol) per 1 g. It may cause a burning sensation on damaged skin.

Method of use:
Always use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

This medicine is intended for use on the skin only. Apply Octizy Gel in a thin layer to the area of skin to be treated until it is completely covered.
Wait at least 1 to 2 minutes before taking any further measures, such as applying a wound dressing. This time is necessary for the product to achieve the desired effect.
Octizy Gel should be used no more than three times a day.
Do not use this medicine for longer than 2 weeks without consulting a doctor.

If you use more Octizy Gel than you should: In the case of a topical medicine, overdose is unlikely. However, if you are concerned, ask your doctor or pharmacist for advice.
If you accidentally swallow Octizy Gel: You should immediately consult a doctor for advice.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Possible side effects:
Rare:
In rare cases, a burning sensation, redness, itching, and a feeling of warmth may occur at the site of application.

Very rare:
Local skin irritation (contact allergic reactions), such as temporary redness of the treated skin, may occur. If Octizi Gel enters the mouth, it temporarily causes a bitter taste.

Additional side effects in children and adolescents:

In premature infants, the use of this medicine may cause a temporary skin rash (erythematous reaction).
The frequency, type, and severity of side effects in children and adolescents are expected to be the same as in adults.

Storage conditions:

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton next to “Expiry date.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After first opening: Store at a temperature not exceeding 25°C.
Shelf life after first opening: 1 year.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

Marketing authorization holder:
EGIS Pharmaceuticals PLC
1106 Budapest, Keresztúri St. 30–38.
Hungary

Do not use more of the medicine than necessary, do not swallow it, and do not allow it to enter the bloodstream, e.g., through accidental injection.
To avoid possible tissue damage, care must be taken during use to ensure that the product is not applied under pressure or injected into tissue.
In the case of cavity wounds (larger, deeper wounds with loss of subcutaneous tissue), adequate drainage of wound fluid must be ensured (for example, by drainage or special wound treatment techniques /so-called skin flap/).
Do not use Octizy Gel in the eyes. In case of contact with the eyes, rinse immediately with plenty of water.