Biafineact is a skin emulsion from the Biafine brand recommended for superficial and small burns, including localized sunburns and uninfected skin wounds.
For warnings, precautions, and contraindications, please refer to the package insert for the over-the-counter medication Biafineact.
Biafineact is a skin care product from the Biafine brand that is recommended for the treatment of superficial and limited-area burns, such as sunburn and uninfected skin wounds.
A first-degree burn is a minor injury characterized by simple redness and dryness of the skin. First-degree burns are superficial because they affect only the upper layers of the epidermis—that is, the outermost layer of the skin. Despite this, they can be very painful.
Applying cold water immediately to a burn has three main effects and follows a very simple rule: the “Rule of 15”—water at 15 degrees, for 15 minutes, held 15 cm from the burn. This helps soothe pain, moisturize the skin, and, most importantly, lower the local temperature.
Biafineact is a skin emulsion from the Biafine brand, specially formulated for superficial and small burns—including localized sunburns—as well as for uninfected skin wounds. This emulsion provides rapid relief and promotes optimal skin healing, ensuring a quick and effective recovery.
Superficial burns can be very painful and require appropriate treatment to promote healing and prevent infections. Biafineact works by forming a protective film on the skin, helping to soothe pain, reduce inflammation, and promote the regeneration of damaged skin tissue. By using this emulsion regularly, you can speed up the healing process and minimize scarring.
Localized sunburn can cause a burning sensation and discomfort on the skin, requiring a soothing treatment to relieve symptoms. Biafineact is particularly recommended for treating localized sunburn, thanks to its gentle, moisturizing formula that helps relieve discomfort and restore sun-damaged skin. By applying this emulsion regularly, you can quickly soothe sunburn and promote effective skin healing.
Biafineact comes in a convenient skin emulsion format, ideal for daily use at home or on the go. Its applicator allows for precise and even application to the affected skin, ensuring optimal relief from sunburn and skin irritations. Thanks to its light, non-greasy texture, this emulsion is easy to spread and absorbs quickly into the skin, leaving an immediate feeling of comfort.
For the treatment of superficial, limited-area burns and localized sunburn, apply a thick layer of Biafine Act 2 to 4 times a day until the skin can no longer absorb it. Gently massage the cream into the skin. Do not continue treatment for more than one week without consulting a doctor.
Skin wounds must be cleaned beforehand, then apply a thick layer of Biafine Act, extending well beyond the area to be treated. Repeat this as often as necessary to ensure that an excess of Biafine Act cream always remains on the surface. If the wound becomes infected or does not improve after one week, consult your doctor.
Biafine Act Burn Emulsion is formulated with: Trolamine 0.67 g / 139.5 g; excipients: ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, avocado oil, sodium trolamine alginate, yerbatone flavoring, purified water.
Please note:Biafineact, an over-the-counter medicationindicated for sunburn and burns, is notlike other products. Read the medication guide carefully before ordering. Keep medications out of the reach of children. If symptoms persist, consult your doctor or pharmacist. Be aware of potential interactions with your current medications.
1. How do I apply Biafineact to burns and skin wounds? First, clean the affected area, then apply a thin layer of the emulsion to the skin, massaging gently. Repeat the application several times a day as needed.
2. Is Biafineact suitable for all ages? Biafineact is suitable for use by adults and children. However, be sure to follow your doctor’s recommendations when using it on young children.
3. How long does it take to see results with Biafineact? Results with Biafineact may vary depending on the severity of the burn or skin wound. However, a significant improvement is usually seen within the first few days of use. If symptoms persist, consult a doctor.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on: 25/07/2017
Name of the medicinal product
BIAFINEACT, emulsion for skin application
trolamine
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
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 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.
What is in this leaflet?
1. What is BIAFINEACT, an emulsion for dermal application and in which cases it is used?
2. What information should be known before using BIAFINEACT, an emulsion for dermal application?
3. How to use BIAFINEACT, emulsion for skin application?
4. What are the possible side effects?
5. How to store BIAFINEACT, an emulsion for skin application?
6. Package contents and other information.
1. WHAT IS BIAFINEACT, an emulsion for skin application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: CUTANEOUS PROTECTOR (D. Dermatology).
· Superficial and small burns, including localized sunburn.
· Uninfected cutaneous wounds.
2. BEFORE YOU USE BIAFINEACT, an emulsion for skin application?
Talk to your doctor or pharmacist before using BIAFINEACT, an emulsion for skin application.
Do not use BIAFINEACT, emulsion for skin application
· if you are allergic to trolamin or any of the other ingredients of this medication mentioned in section 6.
· if you have a wound with bleeding.
· if you have an infected lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
In the event of burning with blistering or extensive burning, or in the case of a deep or extended wound, a medical consultation is essential before applying a medication to the lesion.
This medicine contains propylene glycol and may cause skin irritation.
This medicine contains potassium sorbate and may cause local skin reactions (eg, eczema).
This medicine contains sodium methyl parahydroxybenzoate and soda propyl parahydroxybenzoate and may cause allergic reactions.
This medication is not a sunscreen.
This medication should not be used as a care cream on healthy skin.
Do not apply near eyes.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
children
Not applicable.
Other medicines and BIAFINEACT, emulsion for skin application
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
BIAFINEACT, emulsion for skin application with food and beverages
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or your pharmacist before taking this medicine.
Driving and using machines
Not applicable.
BIAFINEACT, emulsion for dermal application contains propylene glycol, potassium sorbate, sodium methyl parahydroxybenzoate (E 219) and soda propyl parahydroxybenzoate (E 217).
3. HOW TO USE BIAFINEACT, emulsion for skin application?
Always use this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
· Treatment of superficial and small burns, including localized sunburn: Apply in thick layer until skin refuses. Have a light massage. Renew 2 to 4 times a day. Any infected or unhealed burn after one week must be given medical advice.
· Non-infected skin wounds: after wound cleansing, apply in a thick layer, spreading largely over the surface of the lesion and renewing the applications in order to always maintain an excess of emulsion on the lesion. Any infected or unhealed skin wounds after one week must be the subject of a medical opinion.
For the pressurized bottle: in case of blockage, pass the diffuser under lukewarm water. The slight resistance of the diffuser during the first use indicates that the product has never been used.
Administration mode
Dermal.
Use in children
Not applicable.
If you have used more BIAFINEACT, an emulsion for skin application than you should have
Not applicable.
If you forget to use BIAFINEACT, emulsion for skin application
Not applicable.
If you stop using BIAFINEACT, emulsion for skin application
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Moderate and transient pain (tingling) (15 to 30 minutes) that may occur after application.
· Rare contact allergy.
· Very rare cases of contact eczema requiring immediate cessation of treatment.
· The presence of certain excipients may cause skin irritation, or local skin reactions (eg contact dermatitis) or allergic reactions (possibly delayed).
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
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE BIAFINEACT, an emulsion for skin application?
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. The expiry date refers to the last day of that month.
Do not freeze.
For the pressurized vial: Pressurized container. Protect from sunlight, do not expose to temperatures above 50 ° C. Do not pierce, do not throw in the even empty fire.
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 BIAFINEACT contains, emulsion for skin application
· The active substance is:
Trolamine ................................................. .................................................. ......................... 0.670 g
For 100 g of emulsion for dermal application.
· The other components are:
Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, trolamin and sodium alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), parahydroxybenzoate propyl soda (E 217), Yerbatone flavoring, purified water.
What is BIAFINEACT, emulsion for skin application and contents of the outer packaging
This medication is in the form of an emulsion for dermal application, in a tube of 139.5 g or 186 g and in a 50 ml or 150 ml pressurized bottle.
Not all pack sizes may be marketed.
Marketing Authorization Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY LES MOULINEAUX
Marketing Authorization Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY LES MOULINEAUX
Maker
JANSSEN-CILAG
DOMAIN OF MAIGREMONT
27100 VAL DE REUIL
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]
Other
Detailed information on this medicine is available on the ANSM website (France).
Ask your pharmacist or doctor:
If you need more information or advice.
If you are not sure whether this medication is appropriate for you, in particular:
· If you are pregnant or nursing,
· If you have, besides what you want to treat with this medication, another disease,
· If you are taking other medicines at the same time, even if they are sold without a prescription,
· If you have ever been allergic to a drug,
· If you experience any side effect while using this medicine.
Health Education Council
· Only limited and shallow burns that do not touch areas of risk (eyes, face, genitals, bending folds, hands, feet) can be taken care of by yourself
In all cases, the lesions should be immediately cooled by 15 ° C (cold tap water), 15 cm from the burn, for about 15 minutes.
The lesion must then be thoroughly cleaned with an antiseptic solution before application of BIAFINEACT emulsion for skin application.
In the case of "sunburn", the relief provided by the application of BIAFINEACT emulsion for dermal application should not lead to the continuation of solar exposures.
· You must take a medical opinion in the following cases:
o Extent of burn greater than 2% of the surface of the body: in children and the elderly the risk of dehydration in case of extensive burn requires medical advice,
o Burn in the eyes, face, genitals, flexion folds, hands, feet,
o Fever may be a sign of infection,
o Lack of healing after 7 days.
· Simple precautions can prevent domestic accidents or sunburn
o Prevention of domestic burns
Most burns occur at home and during leisure time.
Some precautions prevent them:
§ Adjust the hot water of the valves so that the temperature does not exceed 50 ° C,
§ Systematically turn the handles of the pots and pans towards the inside of the cooker,
§ Keeping children away from the kitchen,
§ Never leave a child under 10 years old, alone at home,
§ Keep children away from the open flame without any protection.
o Prevention of sunburn
BIAFINEACT, emulsion for skin application is not a solar protector. You should use adequate protection when exposed to sunlight.
Some precautions prevent sunburn:
§ Keep a light garment,
§ Apply a sunscreen regularly to ensure a sufficient level of protection,
§ Renew the application of sunscreen after the bath,
§ Avoid the hottest hours of the day.
Skin Protector
trolamine
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
BIAFINEACT: emulsion for dermal application; 139.5 g tube.
-
Laboratory
| p 100 g | |
| trolamine | 0.67 g |
| Propylene glycol | + |
| parahydroxybenzoate | + |
