Active ingredients: Zinc oxide
Zinc oxide Marco Viti 10% ointment
Why is Zinc Oxide used - Generic Drug? What is it for?
Pharmacotherapeutic category
Emollient and Protective
Therapeutic indications
Soothing and protective treatment of eczema, dermatosis and slight abrasions.
Contraindications When Zinc Oxide Should Not Be Used - Generic drug
Hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Zinc oxide - Generic drug
The medicine is to be used for external use only; it can be harmful if swallowed (see Overdose).
Avoid contact of the drug with the eyes; in case of accidental contact, wash abundantly with water.
Do not use the medicine in case of burns or potentially infected wounds.
If the ointment is used for diaper rash, check that the rash improves within a few days; if not, contact your doctor as a different treatment is required.
The use, especially if prolonged, of medicines for local use can give rise to phenomena of irritation or sensitization. In this case, it is necessary to stop the treatment and consult the doctor in order to establish a suitable therapy.
After a short period of treatment without appreciable results, consult your doctor.
Interactions Which drugs or foods can modify the effect of Zinc oxide - Generic drug
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
There are no known interactions with other medicines.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Generally, the use of the ointment during pregnancy and lactation is considered safe when applied in confined areas and for short periods of time.
Pregnancy
No clinical data on exposed pregnancies are available for zinc oxide ointment. This medicine, if used in accordance with the instructions for use, is not absorbed and therefore does not cause systemic effects; in the case of damaged skin, it can be absorbed in minimal quantities.
Feeding time
There are no data on the use of the medicine during lactation and it is not known whether this active substance passes into breast milk. However, since the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach the breast milk.
Effects on ability to drive and use machines
The medicine does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Zinc oxide - Generic drug: Posology
Apply the ointment locally, 1 or 2 times a day, on properly washed and dried skin. Due to its astringent and decongestant action, it can also be used on irritated skin (eg diaper rash).
Apply a layer of ointment to cover the affected area (especially when used to treat diaper rash); in case of sunburn and uninfected skin lesions, it is preferable to apply a thin layer of ointment, using a bandage if necessary.
Perform a light circular massage on the affected area, in order to obtain a partial absorption of the ointment, following which an opaque white residue remains.
The zinc oxide reacts slowly with the fatty acids of oils and fats to give agglomerates of zinc oleate, stearate, etc. In contact with glycerol in the presence of light, a black color can often develop.
Overdose What to do if you have taken an overdose of Zinc Oxide - Generic Drug
There are no reported cases of overdose.
Poor percutaneous absorption of the drug makes overdose symptoms and signs unlikely.
In case of accidental ingestion, the following symptoms may be encountered: diarrhea, nausea and vomiting, hypoglycemia, confusion, fatigue, lethargy, bleeding, jaundice, dark urine, cough, chills and fever, irritation of the oral cavity, kidney problems, copper deficiency. In case of ingestion / intake of Marco Viti zinc oxide, notify your doctor immediately or contact the nearest hospital.
If you have any questions about the use of Marco Viti zinc oxide, ask your doctor or pharmacist.
Side Effects What are the side effects of Zinc Oxide - Generic Drug
Like all medicines, Marco Viti zinc oxide can cause side effects, although not everybody gets them.
Below are the side effects of zinc oxide. Insufficient data are available to establish the frequency of the individual effects listed.
Disorders of the immune system
Allergic / hypersensitivity reaction: rash, hives, itching and / or swelling (especially of the face, tongue, throat, lips), tightness in the chest, difficulty in breathing.
Skin and subcutaneous tissue disorders
Skin irritation.
Burning, tingling and dark spots on the skin.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date indicated on the package.
Conservation conditions
Store in tightly closed container, protected from light.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children.
Other information
Composition
100 g of ointment contain
- Active ingredient: zinc oxide 10 g
- Excipients: white petroleum jelly, liquid paraffin.
Pharmaceutical Form and Content
Ointment 30 g tube.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ZINC OXIDE MARCO VITI 10% OIL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of ointment contain
Active ingredient: zinc oxide 10.0 g.
For a full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Ointment.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Soothing and protective treatment of eczema, dermatosis and slight abrasions.
04.2 Posology and method of administration
Apply the ointment locally, 1 or 2 times a day, on properly washed and dried skin. Due to its astringent and decongestant action, it can also be used on irritated skin (eg diaper rash).
Apply a layer of ointment to cover the affected area (especially when used to treat diaper rash); in case of sunburn and uninfected skin lesions, it is preferable to apply a thin layer of ointment, using a bandage if Perform a light circular massage on the affected area, in order to obtain a partial absorption of the ointment, following which an opaque white residue remains.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
The medicine should be used for external use only; it can be harmful if swallowed (see section 4.9).
Avoid contact of the drug with the eyes; in case of accidental contact, wash abundantly with water. Do not use the medicine in case of burns or potentially infected wounds.
If the ointment is used for diaper rash, check that the rash improves within a few days; otherwise, a different treatment must be used.
The use, especially if prolonged, of medicines for local use can give rise to phenomena of irritation or sensitization. In this case, it is necessary to interrupt the treatment and institute a suitable therapy.
04.5 Interactions with other medicinal products and other forms of interaction
None known.
04.6 Pregnancy and lactation
Generally, the use of the ointment during pregnancy and lactation is considered safe when applied in confined areas and for short periods of time.
Pregnancy
No clinical data on exposed pregnancies are available for zinc oxide ointment.
This medicine, if used in accordance with the instructions for use, is not absorbed and therefore does not cause systemic effects; in the case of damaged skin, it can be absorbed in minimal quantities.
Feeding time
There are no data on the use of the medicine during lactation and it is not known whether this active substance passes into breast milk. However, since the absorption of the drug can be considered negligible, it is very unlikely that significant quantities reach the breast milk.
04.7 Effects on ability to drive and use machines
The medicine does not affect the ability to drive or use machines.
04.8 Undesirable effects
The following are the undesirable effects of zinc oxide organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed.
Disorders of the immune system
Allergic / hypersensitivity reaction: rash, hives, itching and / or swelling (especially of the face, tongue, throat, lips), tightness in the chest, difficulty in breathing.
Skin and subcutaneous tissue disorders
Skin irritation.
Burning, tingling and dark spots on the skin.
04.9 Overdose
There are no reported cases of overdose.
Poor percutaneous absorption of the drug makes overdose symptoms and signs unlikely.
In case of accidental ingestion, the following symptoms may be encountered: diarrhea, nausea and vomiting, hypoglycemia, confusion, fatigue, lethargy, bleeding, jaundice, dark urine, cough, chills and fever, irritation of the oral cavity, kidney problems, copper deficiency.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: emollient and protective.
ATC code: D02AB.
Zinc oxide has soothing properties and is a weak astringent and antiseptic.
Applied locally on irritated and damaged skin, it acts by forming a barrier on the skin that provides protection against irritants and humidity.
05.2 Pharmacokinetic properties
In the case of intact skin, the ointment is poorly absorbed following local application.
05.3 Preclinical safety data
Preclinical data are insufficient and have little clinical relevance in light of the vast experience acquired with the use of the drug in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
White petroleum jelly, liquid paraffin.
06.2 Incompatibility
The zinc oxide reacts slowly with the fatty acids of oils and fats to give agglomerates of zinc oleate, stearate, etc.
In contact with glycerol in the presence of light, a black color can often develop.
06.3 Period of validity
5 years
06.4 Special precautions for storage
Store in the original container protected from light.
06.5 Nature of the immediate packaging and contents of the package
30 g aluminum tube.
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 - 36100 Vicenza
08.0 MARKETING AUTHORIZATION NUMBER
030360010
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization December 1993
10.0 DATE OF REVISION OF THE TEXT
AIFA determination of 29 July 2011
