Oxyplastine 46% Ointment Tube 135 g on sale in our pharmacy Bio is a drug that is indicated in case of irritation of the skin, especially in case of diaper dermatitis (red buttocks) in infants.
For warnings, precautions for use and contraindications, please consult the instructions for use of OXYPLASTINE 46% Zinc oxide ointment.
Oxyplastine 46% Ointment Tube 135 g is a protective ointment that contains zinc oxide . It is used to treat skin irritations and especially in cases of diaper rash (red buttocks) in infants.
Clean the area to be treated before use. Apply a thin layer 1 to 2 times a day, for 5 days in the event of skin irritation, and three days in the event of redness on the buttocks of the infant.
The active substance is : zinc oxide.
The other ingredients are : cholesterol, white beeswax, purified water, wool grease, calcium hydroxide, virgin castor oil.
Never use OXYPLASTINE 46% ointment :
Caution with OXYPLASTINE 46% ointment :
Pregnancy
Ask your pharmacist for advice before taking any medicine.
Feeding with milk
Do not apply to breasts during breastfeeding due to the risk of ingestion by the newborn.
Contains wool fat or lanolin.
Skin irritations are frequent and manifest in various ways: when it is acute, the skin will appear red and slightly swollen; when it is more chronic, the skin will be more dry and cracked, which can sometimes itch. On the body, the skin can even crack and peel.
Skin irritation can be caused by different things. On the one hand friction (with rough clothes or skin against skin during sports), excessive sweating or after shaving. On the other hand, skin irritation can be caused by irritants: unsuitable makeup, household cleaners, creams, etc.
135 g tube of ointment.
Attention, the drug Oxyplastine is not a product like the others. Read the instructions for the drug Oxyplastine carefully before ordering it. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: 03/10/2016
Zinc oxide
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
1. What is OXYPLASTINE 46%, Ointment and in which cases is it used?
2. What should I know before using OXYPLASTINE 46% Ointment?
3. How to use OXYPLASTINE 46%, ointment?
4. What are the possible side effects?
5. How to store OXYPLASTINE 46%, ointment?
6. Package contents and other information.
1. WHAT DOES OXYPLASTINE 46%, Ointment AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: SKIN PROTECTOR - ATC code: D02AB
2. WHAT TO DO ABOUT BEFORE USING OXYPLASTINE 46%, Ointment?
Never use OXYPLASTINE 46%, ointment:
· if you are allergic (hypersensitive) to zinc oxide or any of the other ingredients of this medication mentioned in section 6, such as wool fat or lanolin.
· in case of oozing lesions
· in case of superinfected lesions.
Warnings and Precautions
Talk to your doctor or pharmacist before using OXYPLASTINE .
Take special care with OXYPLASTINE 46%, ointment:
Special warnings:
Observe the instructions for use:
· never apply a dose higher than recommended ( see "Posology" );
· do not apply over an extended area of the body;
· respect the frequency and duration of treatment recommended.
Precautions for use:
This medication contains wool fat (lanolin) and may cause skin reactions (eg, eczema).
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
children
Not applicable.
Other drugs and OXYPLASTINE 46%, ointment
The evidence available to date does not suggest the existence of clinically significant interactions.
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
OXYPLASTINE 46%, ointment with food and drink
Not applicable.
Pregnancy
Ask your pharmacist for advice before taking any medicine.
feeding
Do not apply on the breasts during breastfeeding because of the risk of ingestion by the newborn.
Sport
Not applicable.
Driving and using machines
Not applicable.
OXYPLASTINE 46%, ointment contains wool fat or lanolin.
3. HOW TO USE OXYPLASTINE 46%, Ointment?
Apply locally 1 to 2 times a day.
Administration mode :
Dermal.
Duration of the treatment :
Skin irritation: duration of use limited to 5 days.
Red buttocks of the infant: duration of use limited to 3 days.
If there is no improvement as in the case of persistent symptoms, take a medical opinion.
If you used more OXYPLASTINE 46% Ointment than you should:
Not applicable.
If you forget to use OXYPLASTINE 46%, ointment:
If you stop using OXYPLASTINE 46%, ointment:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE OXYPLASTINE 46%, ointment?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package .
Store at a temperature not exceeding 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What OXYPLASTINE contains 46%, ointment
· The active substance is:
Zinc oxide............................................... .................................................. .................. 46 g.
For 100 g of ointment
· The other components are:
Cholesterol, white beeswax, wool fat (lanolin), purified water, calcium hydroxide, virgin castor oil.
What is OXYPLASTINE 46%, ointment and contents of the pack
This medication is in the form of an ointment.
Tube of 65 g or 135 g.
Marketing Authorization Holder
ALLIANCE PHARMA France SAS
35, RUE D'ARTOIS
75008 PARIS
Marketing Authorization Operator
ALLIANCE PHARMA France SAS
35, RUE D'ARTOIS
75008 PARIS
93 ROAD OF CURRENCY
37210 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Detailed information on this medicine is available on the ANSM website (France).
Health education councils:
In order to limit the risk of infant rash, it is necessary to:
· change the baby frequently, at least 6 times a day,
· at each change, clean the baby's buttocks with soap by insisting on the folds and then rinse thoroughly with water,
· dry thoroughly with a clean absorbent towel, without rubbing to avoid the risk of irritation.
In case of diaper rash of the infant, it is also recommended to leave the buttocks of the baby in the air as often as possible and as long as possible.
Skin Protector
zinc oxide
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
OXYPLASTINE: ointment; 135 g tube.
-
Laboratory Sinclair Pharma France
p 100 g | |
Zinc oxide | 46 g |
Lanolin | 4 g |
Usual dosage:
1 or 2 applications per day.