Important safety information and consumer warnings you should know about benzoyl peroxide.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Benzoyl Peroxide (Benzoyl)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Benzoyl Peroxide carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- What Benzoyl Peroxide is and what it is used for 2. Before you use Benzoyl Peroxide
- How to use Benzoyl Peroxide
- Possible side effects
- How to store Benzoyl Peroxide
- Further information
1. WHAT BENZOYL PEROXIDE IS AND WHAT IT IS USED FOR
Benzoyl Peroxide works by killing bacteria on your skin that cause acne.
Benzoyl Peroxide is used to treat moderate acne (spots).
It helps to:
- reduce the number of spots
- stop new blackheads, whiteheads and spots from forming.
Benzoyl Peroxide is for use by adults and adolescents aged twelve years or over.
2. BEFORE YOU USE Benzoyl Peroxide
Do not use Benzoyl Peroxide if:
- if you are allergic (hypersensitive) to benzoyl peroxide or any of the other ingredients (listed in Section 6). Do not use Benzoyl Peroxide if the above applies to you. If you are not sure, ask your pharmacist or doctor before you use this medicine.
Take special care with Benzoyl Peroxide
- Only use Benzoyl Peroxide on your skin. Keep it away from areas like your eyes, eyelids, lips, mouth and inside the nose. If contact with these areas occurs, immediately wash the affected area with water.
- Take care to avoid using Benzoyl Peroxide on broken skin; for example, if you have cuts or grazes.
- Take care when using Benzoyl Peroxide on areas of sensitive skin such as your neck.
- Benzoyl Peroxide can make your skin more sensitive to the harmful effects of the sun. Avoid the use of sunbeds/ lamps and minimise the time you spend in the sun. You should use a sunscreen and wear protective clothing while using Benzoyl Peroxide.
- Avoid contact with hair, dyed or coloured fabrics (including clothing, towels and bed linen) furniture or carpeting. Benzoyl Peroxide can bleach these materials.
Do not give this medicine to children under twelve years. It is not known if it works or if it is safe for them.
Using other medicines
Tell your pharmacist or doctor if you are taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes medicines bought without a prescription.
In particular, please tell your doctor or pharmacist:
- if you are using any other acne treatment. If used at the same time, it may make skin irritation worse
- if you are using other acne medicines containing tretinoin, isotretinoin or tazarotene. If used at the same time, Benzoyl Peroxide may make these treatments less effective
- if you are using sulfonamide-containing products such as dapsone and sulfacetamide. If used at the same time as Benzoyl Peroxide, your skin or facial hair may turn yellow or orange. This will not be permanent.
Check with your doctor or pharmacist if you think any of these may apply to you. Your doctor or pharmacist will decide if you should take Benzoyl Peroxide with these medicines or you may need to use your medicines at different times of the day (for example, one in the morning and the other at bedtime).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before using Benzoyl Peroxide, if you are pregnant or breast-feeding. There is only limited information about the safety of Benzoyl Peroxide in pregnant women.
- Tell your doctor or pharmacist if you are pregnant, planning to become pregnant or become pregnant during treatment with Benzoyl Peroxide.
It is not known whether benzoyl peroxide can pass into breast milk. If you are breast-feeding, you must check with your doctor or pharmacist before you use Benzoyl Peroxide
- Do not use Benzoyl Peroxide on your breast if you are breast-feeding.
Important information about some of the ingredients of Benzoyl Peroxide
- Benzoyl Peroxide contains propylene glycol alginate. This may cause skin irritation.
- Benzoyl Peroxide also contains stearyl alcohol and cetyl alcohol. These may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE Benzoyl Peroxide
Always use Benzoyl Peroxide exactly as your doctor or pharmacist has told you to. Check with a doctor or pharmacist if you are not sure.
- Use Benzoyl Peroxide once or twice a day as instructed by your doctor or pharmacist.
- Start with one application daily, preferably in the evening, then gradually increase to twice daily (morning and evening) as instructed.
- During the first weeks of treatment a sudden increase in peeling and reddening of the skin will occur in most people. If this causes you problems, try using Benzoyl Peroxide less often, or stop using it for a few days until the irritation goes away then start again. Stop using Benzoyl Peroxide if the irritation does not go away.
- It may take 4 to 6 weeks before you see an improvement of your skin. You may need to use this treatment for longer before you see the full effects. This is normal for acne treatments.
- After 6 to 8 weeks if your acne is no better or it gets worse, talk to your doctor or pharmacist.
- Use Benzoyl Peroxide for as long as your doctor or pharmacist tells you to. Continue using this medicine until the acne has gone.
- Do not stop using it without asking for advice. If you stop too soon your acne may come back.
How to apply Benzoyl Peroxide
- Completely remove any make-up.
- Wash your hands and the affected area and gently dry.
- Put a thin layer of Benzoyl Peroxide cream on the affected skin, using your fingertips. If the cream does not rub into your skin easily, you are using too much.
- Apply to all of the area of your skin that has acne, not just each spot. You may notice a mild burning sensation. If this becomes severe, stop using Benzoyl Peroxide and see your doctor.
- Take care not to use too much Benzoyl Peroxide. Applying too much, or more often than advised, will not help your acne clear up more quickly and may cause skin irritation.
- Wash your hands after using the cream.
If you forget to use Benzoyl Peroxide
• Do not use a double dose to make up for forgotten doses. • Apply the next dose at the usual time.
If you accidentally swallow Benzoyl Peroxide
• Contact your doctor or pharmacist for advice. If you accidentally get Benzoyl Peroxide in your mouth, rinse it with plenty of water.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Benzoyl Peroxide can cause side effects, although not everybody gets them.
Severe allergic reactions:
Severe allergic reactions have occurred in a very small number of people but their exact frequency is not known. Signs include:
- raised and itchy rash (hives)
- swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing • collapse.
Contact a doctor immediately if you get these symptoms. Stop taking Benzoyl Peroxide immediately.
Other side effects include:
Very common: may affect more than 1 in 10 people
- peeling of the skin and redness at the site of application
Common: may affect up to 1 in 10 people
- dryness, itching or sensitivity of the skin at the site of application
Uncommon: may affect up to 1 in 100 people:
- burning sensation.
Not known (cannot be estimated from the available data)
At the site of application:
- discoloration of the skin
- other skin reactions such as irritation and pain.
Tell your doctor or pharmacist if any of these side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE Benzoyl Peroxide
- Keep out of the reach and sight of children.
- Do not store above 25°C.
- Do not use Benzoyl Peroxide after the expiry date which is printed on the tube and carton.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Benzoyl Peroxide contains
- The active ingredient is benzoyl peroxide. Benzoyl Peroxide contains 4% w/w benzoyl peroxide.
- The other ingredients are: cetyl alcohol, stearyl alcohol, macrogol cetostearyl ether, simethicone emulsion, propylene glycol alginate, dimethyl isosorbide, fragrance (X-23304) and water.
What Benzoyl Peroxide looks like and contents of the pack
Benzoyl Peroxide Cream is a white to off white cream and comes in 50g tubes.