Diclofenac 4% Pain & Inflammation Spray 25 ml is a topical medication indicated for adults and adolescents 14 years of age and older for the short-term local treatment of mild to moderate pain and inflammation following a blow or sprain. Its spray applicator allows for precise application to small and medium-sized joints.
For warnings, precautions, and contraindications, please refer to the package insert for Diclofenac 4% Pain & Inflammation Spray 25 ml.
Diclofenac 4% Pain & Inflammation Spray is a medication intended for the short-term, topical treatment of pain and inflammation caused by acute blunt trauma. In particular, it can be used after a bump, blow, or mild sprain affecting a small or medium-sized joint, as well as the surrounding tissues.
This topical spray is suitable for adults and adolescents 14 years of age and older. It can be used when pain is mild to moderate and accompanied by localized signs of inflammation, such as tenderness, discomfort during movement, or moderate swelling. Its design allows for precise treatment of the affected area without having to directly touch the skin when spraying.
Its active ingredient, diclofenac sodium, belongs to the family of nonsteroidal anti-inflammatory drugs, also known as NSAIDs. Once applied to the skin, it acts locally on the mechanisms responsible for pain and inflammation. Its action can be compared to that of a regulator that gradually reduces the inflammatory signals emitted by tissues following an injury.
This local action helps soothe the affected area, reduce inflammation, and promote joint comfort. The treatment aims to make everyday movements more bearable, without masking the need to temporarily rest the joint when it has suffered an impact or a twist.
Diclofenac 4% Pain & Inflammation Spray should be used for a short period of time. If you do not notice any improvement, if your symptoms worsen, or if you feel worse after 3 days, consult your doctor. Treatment should not be continued for more than 7 days without medical advice.
If you are looking for a topical solution that provides prolonged release of diclofenac, you may want to consider VoltarenActigo Medicated Patch. Since both of these medications contain an NSAID, do not apply them simultaneously to the same area or use them together without consulting your doctor or pharmacist.
Directions for Use
Diclofenac 4% Pain & Inflammation Spray is intended for adults and adolescents over 14 years of age.
Apply 4 to 5 sprays to the painful area, 3 times a day, at regular intervals. Adjust the number of sprays according to the size of the area to be treated, without exceeding 5 sprays per application.
The maximum daily dose is 15 sprays. Gently massage the area after spraying to help the solution absorb.
Treatment should not exceed 7 days without medical advice. Consult a doctor if symptoms persist or worsen after 3 days of use.
Share your feedback on the usage instructions and dosage of Diclofenac 4% Pain & Inflammation Spray with our partner Avis Vérifiés after your purchase.
Precautions
Ingredients:
Propylene Glycol (E1520), Isopropanol, Soy Phospholipids, 96% Ethanol, Sodium Phosphates, Disodium Edetate, Ascorbyl Palmitate, Peppermint Essential Oil, Hydrochloric Acid, Sodium Hydroxide, Purified Water.
Active ingredient – Per 1 mL of solution:
Diclofenac sodium ........................................................................................................ 40 mg
Equivalent to, per injection .................................................................................................. 8 mg
Read the package insert carefully before use. If in doubt, ask your doctor or pharmacist for advice.
Product Information:
Diclofenac 4% Pain & Inflammation comes in a 25-ml spray bottle for topical application. Available at the best price in our online pharmacy.
After a minor injury, rest the joint for the first few hours and avoid movements that trigger pain. You can briefly apply a cold pack wrapped in a cloth, without placing the ice directly on the skin. Wait until the skin is clean, dry, and has returned to normal temperature before using the spray. Severe pain, deformity, significant swelling, extensive bruising, or an inability to move the joint warrant prompt medical attention.
At what age can Diclofenac 4% Pain & Inflammation Spray be used?
This medication can be used by adults and adolescents 14 years of age and older. It should not be used by children under 14 years of age.
How many sprays can be applied per day?
You can apply 4 to 5 sprays per application, 3 times a day. Do not exceed 5 sprays per application or a total dose of 15 sprays per day.
How long can this diclofenac spray be used?
Treatment should not exceed 7 days without medical advice. Consult a doctor if the pain or inflammation does not improve, or if it worsens after 3 days.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Updated on: June 8, 2026
DICLOFENAC URGO 4%, solution for topical spray
diclofenac sodium
You should always use this medication exactly as described in this leaflet or as directed by your doctor or pharmacist.
· Keep this package insert. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See Section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse after 3 days.
What is in this package insert?
1. What is DICLOFENAC URGO 4%, solution for topical spray, and what is it used for?
2. What should you know before using DICLOFENAC URGO 4%, solution for topical spray?
3. How should you use DICLOFENAC URGO 4%, skin spray solution?
4. What are the possible side effects?
5. How should you store DICLOFENAC URGO 4%, skin spray solution?
6. Package contents and other information.
1. WHAT IS DICLOFENAC URGO 4%, skin spray solution, AND WHAT IS IT USED FOR?
This medication is used in adults and adolescents over 14 years of age for the short-term, local symptomatic treatment of mild to moderate pain and inflammation resulting from acute blunt trauma to small and medium-sized joints and surrounding structures.
You should consult your doctor if you do not experience any improvement or if you feel worse after 3 days.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE USING DICLOFENAC URGO 4%, skin spray solution?
Never use DICLOFENAC URGO 4%, skin spray solution:
· If you are allergic to diclofenac or any of the other ingredients in this medication (listed in Section 6).
· If you are allergic to peanuts or soy, as it contains soy lecithin.
· If you have ever had an allergic reaction with difficulty breathing (asthma), skin rash, runny nose, or swelling of the face or tongue caused by a medication used to relieve pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acid (also used as an anticoagulant).
· On an open wound, inflamed or infected skin, or on eczema or mucous membranes.
· During the last three months of pregnancy, please refer to the “Pregnancy and Breastfeeding” section.
Warnings and Precautions
Consult your doctor or pharmacist before using DICLOFENAC URGO 4%, skin spray solution:
· If you have a history of asthmatic bronchitis or allergies.
· If the spray accidentally gets into your eyes, rinse thoroughly with clean water and inform your doctor.
· Never swallow DICLOFENAC URGO 4%, skin spray solution.
· Stop using DICLOFENAC URGO 4%, skin spray solution, if a rash develops after application.
· Do not cover the treated area with occlusive dressings or bandages (waterproof or non-breathable).
· Do not expose the treated areas to sunlight and do not use UV lamps.
There may be a risk of systemic side effects associated with the use of DICLOFENAC URGO 4%, skin spray solution, if the medication is used on large areas of skin and over an extended period. The occurrence of side effects can be minimized by using the lowest effective dose for the shortest duration of treatment necessary to relieve symptoms.
Danger: Flammable. Keep away from heat, hot surfaces, sparks, open flames, and any other sources of ignition.
Children and Adolescents
Do not use this medication in children and adolescents under 14 years of age.
Other Medications and DICLOFENAC URGO 4%, Skin Spray Solution
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.
Consult your doctor before using DICLOFENAC URGO 4%, skin spray solution:
· If you are taking medications containing diclofenac, acetylsalicylic acid, or any other NSAID, such as ibuprofen.
Using other NSAIDs (including acetylsalicylic acid or ibuprofen) at the same time as DICLOFENAC URGO 4%, skin spray solution may increase the risk of side effects.
If you are pregnant or breastfeeding, if you think you might be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before using this medication.
Pregnancy
DICLOFENAC URGO 4%, skin spray solution, should not be used during the last 3 months of pregnancy, as it may increase the risk of complications for the mother and the newborn.
DICLOFENAC URGO 4%, skin spray solution, should only be used under medical supervision during the first 6 months of pregnancy, and the dose should be kept as low as possible and the duration of treatment as short as possible.
Oral forms (e.g., tablets) of DICLOFENAC URGO 4%, skin spray solution may cause adverse effects in your unborn child. With DICLOFENAC URGO 4%, skin spray solution, when used on the skin, this risk is not known.
Breastfeeding
Do not use DICLOFENAC URGO 4%, skin spray solution while breastfeeding, unless otherwise directed by your doctor.
However, DICLOFENAC URGO 4%, skin spray solution, should not be applied to the breasts of breastfeeding mothers, to large areas of skin, or for an extended period of time.
Driving and Operating Machinery
Topical application of DICLOFENAC URGO 4%, skin spray solution does not affect the ability to drive or operate machinery.
DICLOFENAC URGO 4%, topical spray solution contains propylene glycol (E1520), ethanol, and soy lecithin
This medication contains 30 mg of propylene glycol (E1520) per pump.
This medication contains 6.65 mg of alcohol (ethanol) per pump.
This medication contains soybean oil. If you are allergic to peanuts or soy, do not use this medication.
3. HOW TO USE DICLOFENAC URGO 4%, solution for topical spray?
The recommended dose is:
Adults and adolescents over 14 years of age:
Apply 4–5 pumps 3 times a day at regular intervals. The number of pumps depends on the size of the affected area. The maximum dose should not exceed 5 pumps at a time. The maximum daily dose is 15 pumps.
Treatment may be discontinued once symptoms (pain and swelling) have subsided.
Do not continue treatment for more than 7 days without consulting a doctor.
Tell your doctor if symptoms worsen or persist after 3 days of treatment.
Use in Children and Adolescents
Do not use in children and adolescents under 14 years of age.
DICLOFENAC URGO 4%, solution for topical spray, is intended for topical use only. Follow the instructions carefully:
· Remove the clear protective cap from the pump.
· Before first use, press the pump four times to prime it. Discard the product dispensed during these presses. If the pump is not primed, a lower dose may be applied during the first use.
· Wash and dry the painful area. Apply the spray to the affected areas of the body and massage gently to help it absorb into the skin. Then wipe your hands with a paper towel and wash them, unless the area to be treated is your hands.
· If too much spray is accidentally applied, wipe off the excess with a paper towel.
· Dispose of the paper towel with household trash to prevent unused product from entering the aquatic environment.
· Before applying a bandage, allow the spray to dry on the skin for a few minutes.
If you have used more DICLOFENAC URGO 4%, skin spray solution than you should have
If you apply more medication than you should have, wipe off the excess with a paper towel.
If you swallow any of the product, tell your doctor immediately or go to the emergency room at the nearest hospital. Take the bottle and the package insert with you.
If you forget to use DICLOFENAC URGO 4%, skin spray solution
If you have any other questions about the use of this medication, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medications, this medication may cause side effects, but they do not occur in everyone.
Stop using DICLOFENAC URGO 4%, skin spray solution if a rash develops. Reactions at the application site have been frequently reported following topical use (applied to the skin) of diclofenac preparations. These include skin rashes, itching, redness, a burning sensation, or peeling of the skin.
Some rare and very rare side effects can be serious:
If you experience any of the following signs of an allergic reaction, stop using DICLOFENAC URGO 4%, skin spray solution, and consult a doctor immediately.
· Rare (may affect up to 1 in 1,000 people): Skin rash with blisters.
· Very rare (may affect up to 1 in 10,000 people): Wheezing, shortness of breath, or a feeling of tightness in the chest (asthma). Hypersensitivity reactions, including hives (red, raised welts, often accompanied by itching and a burning sensation). Swelling of the face, lips, tongue, or throat.
Other side effects may occur, but they are often mild and temporary. If you notice any, talk to your doctor or pharmacist as soon as possible.
· Common (may affect up to 1 in 10 people): Skin rash, itching, redness, or skin irritation after using the medication.
· Uncommon (may affect up to 1 in 100 people): Dandruff, dry skin, edema.
· Very rare (may affect up to 1 in 10,000 people): The skin may be more sensitive to the sun (photosensitivity). Possible signs include sunburn with itching, swelling, and blisters. Pustular rash. Gastrointestinal disorders.
· Systemic side effects such as pain and stomach problems, heartburn, liver or kidney problems, and hypersensitivity reactions may occur if the medication is used for a prolonged period and/or on large areas of skin.
Reporting Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package insert. You can also report adverse effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers—Website: https://signalement.social-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of this medication.
5. HOW SHOULD DICLOFENAC URGO 4%, solution for topical spray, BE STORED?
Keep this medication out of the sight and reach of children.
Store in the original packaging, protected from light.
Do not use this medication after the expiration date printed on the package and on the bottle after “EXP.” The expiration date refers to the last day of that month.
Do not use this medication more than 6 months after first opening.
Do not dispose of any medication down the drain or with household trash. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What DICLOFENAC URGO 4%, solution for topical spray, contains
· The active ingredient is diclofenac sodium.
Each milliliter of skin spray solution (equivalent to 5 pumps) contains 40 mg of diclofenac sodium.
Each pump (0.2 mL of solution) contains 8 mg of diclofenac sodium.
· The other ingredients are: propylene glycol (E1520), isopropanol, Phospholipon 90G (containing phosphatidylcholine derived from soy lecithin and lysophosphatidylcholine, nonpolar lipids, and tocopherol), 96% ethanol, disodium phosphate, sodium dihydrogen phosphate dihydrate, disodium edetate, ascorbyl palmitate, propylene glycol, peppermint essential oil, diluted hydrochloric acid, 10% sodium hydroxide solution, and purified water.
What is DICLOFENAC URGO 4%, solution for topical spray, and contents of the outer packaging
DICLOFENAC URGO 4%, skin spray solution is a yellowish solution.
A 30 mL amber glass bottle containing 25 g of skin spray solution (125 sprays), equipped with a polypropylene pump and a polyethylene dip tube.
Marketing Authorization Holder
12 RUE DAUPHINE
21000 DIJON
Marketing Authorization Holder
URGO HEALTHCARE LABORATORIES
12 Rue Dauphine
21000 DIJON
ARMANDO MARTINS TAVARES INDUSTRIAL PARK,
Rua Outeiro da Armada, 5,
3150-194 CONDEIXA-A-NOVA
PORTUGAL
OR
FARMALIDER, S.A.
Calle Aragoneses 2,
28108, ALCOBENDAS, MADRID
SPAIN.
Names of the medication in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with applicable regulations.
[To be completed later by the marketing authorization holder]
The date this package insert was last revised is:
[To be completed later by the marketing authorization holder]
Detailed information about this medication is available on the ANSM (France) website.
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