Zinc oxide Marco Viti

Zinc Oxide Marco Viti 10% ointment

Package leaflet

Marco Viti Farmaceutici S.p.A.
Zinc Oxide Marco Viti 10% ointment
Therapeutic Category
Emollient and Protective
Therapeutic Indications
Soothing and protective treatment of eczema, dermatoses and minor abrasions.
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Precautions for Use
This medicine is for external use only; it may be harmful if swallowed (see Overdose).
Avoid contact of the medicine with the eyes; in case of accidental contact, wash thoroughly with water.
Do not use the medicine on burns or potentially infected wounds.
If used for diaper dermatitis, monitor that the skin rash improves within a few days; otherwise, contact a doctor, as a different treatment may be required.
The use, especially prolonged use, of topical medicines may lead to irritation or sensitization. In such cases, treatment should be discontinued and medical advice sought to initiate appropriate therapy.
If there is no noticeable improvement after a short period of treatment, consult a doctor.
Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those not
requiring a prescription.
No interactions with other medicines are known.
Special Warnings
Pregnancy and Breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Generally, the use of the ointment during pregnancy and breastfeeding is considered safe when applied to limited areas and for short periods.
Pregnancy
Clinical data on pregnancies exposed to zinc oxide ointment are not available.
When used according to the recommended instructions, this medicine is not absorbed and therefore does not produce systemic effects; however, when applied to damaged skin, it may be absorbed in minimal amounts.
Breastfeeding
No data are available on the use of this medicine during breastfeeding, and it is not known whether the active substance passes into breast milk. However, since absorption of the medicine is considered negligible, it is highly unlikely that significant amounts would reach breast milk.
Effects on ability to drive vehicles and use machinery
This medicine does not affect the ability to drive vehicles or operate machinery.
Dosage, method and duration of administration
Zinc Oxide Marco Viti 10% ointment

Package leaflet

Marco Viti Farmaceutici S.p.A.
Apply the ointment locally, 1 or 2 times daily, to skin that has been properly washed and dried. Due to its
astringent and decongestant action, it may also be used on irritated skin (e.g. diaper dermatitis).
Apply a layer of ointment sufficient to cover the affected area (especially when used for the treatment of
diaper dermatitis); in case of burns and non-infected skin lesions, it is preferable to apply a thin layer of
ointment, using a dressing if necessary.
Perform a gentle circular massage on the affected area to achieve partial absorption of the ointment, after
which a white, opaque residue remains.
Zinc oxide reacts slowly with fatty acids in oils and fats to form aggregates of zinc oleate, stearate, etc.
In contact with glycerol and exposed to light, a dark discoloration may often develop.
Overdose
No cases of overdose have been reported.
The low percutaneous absorption of the drug makes the occurrence of symptoms and signs due to overdose
unlikely.
In case of accidental ingestion, the following symptoms may occur: diarrhea, nausea and vomiting,
hypoglycemia, confusion, fatigue, lethargy, bleeding, jaundice, dark urine, cough, chills and fever, irritation
of the oral cavity, renal disorders, copper deficiency.
In case of accidental ingestion/ingestion of zinco ossido Marco Viti, immediately contact a physician or go to
the nearest hospital.
If you have any doubts about the use of zinco ossido Marco Viti, consult your doctor or pharmacist.
Undesired effects
Like all medicines, zinco ossido Marco Viti can cause unwanted effects, although not everyone experiences
them.
Listed below are the undesirable effects of zinc oxide. There are insufficient data available to establish the
frequency of the individual listed effects.
Immune system disorders
Allergic/hypersensitivity reaction: rash, urticaria, itching and/or swelling (especially of the face, tongue,
throat, lips), feeling of tightness in the chest, difficulty breathing.
Skin and subcutaneous tissue disorders
Skin irritation.
Burning, tingling, and dark skin spots.
Following the instructions contained in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsen, or if you notice any undesirable effect not listed in this leaflet,
inform your doctor or pharmacist.
Expiry date and storage
Expiry date: see the date on the packaging.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.
WARNING: do not use the medicine after the expiry date stated on the packaging.
Zinco ossido Marco Viti 10% ointment

Package Leaflet

Marco Viti Farmaceutici S.p.A.
Storage Conditions
Store in a tightly closed container, protected from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Composition
100 g of ointment contain:
Active substance: zinc oxide 10 g
Excipients: white vaseline, liquid paraffin.
Pharmaceutical Form and Contents
Ointment
30 g tube
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza
Responsible Producer for Batch Release
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
AIFA Determination of 29 July 2011