Brand Name
US Brand Name
Acne
Acne 10 Gel
Acne Wash
Benzac
Benzagel
Benzashave
BenzEFoam Ultra
Benziq
Binora
BPO 4% Gel
BPO 8% Gel
Brevoxyl
Canadian Brand Name
10 Benzagel Acne Gel
2.5 Benzagel Acne Gel
2.5 Benzagel Acne Lotion
5 Benzagel Acne Gel
5 Benzagel Acne Lotion
5 Benzagel Acne Wash
Acetoxyl 10
Acetoxyl 2.5
Acetoxyl 20
Acetoxyl 5
Acnomel Bp 5
Alquam-X Acne Therapy Gel
Description
Benzoyl peroxide topical is used to treat acne and may be used for other skin conditions as determined by your doctor. Epsolay® topical cream is used to treat inflammatory lesions (pimples and red bumps) caused by rosacea.
Epsolay® topical cream is available only with your doctor's prescription. Some of the skin products are available without prescription.
This product is available in the following dosage forms:
- Soap
- Gel/Jelly
- Lotion
- Liquid
- Foam
- Cream
- Pad
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Epsolay® topical cream in the pediatric population. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of benzoyl peroxide topical have not been performed in children 12 years of age and older, no pediatric-specific problems have been documented to date.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Epsolay® topical cream in the elderly.
Although appropriate studies on the relationship of age to the effects of benzoyl peroxide topical have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Dermatitis, seborrheic or
- Eczema (skin problem) or
- Sunburn—May cause skin irritation in patients with these conditions.
Proper Use
It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to be irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
This medicine is for use on the skin only. Do not get it in your eyes, nose, lips, mouth, or vagina. Do not use on skin areas that have cuts, scrapes, or sunburn. If it does get on these areas, rinse it off right away.
Before using an OTC acne product for the first time, apply a small amount to one or two small affected areas of the skin for 3 days. If no discomfort occurs, follow the directions on the drug facts label of the product.
Wash your hands with soap and water before and after you use this medicine.
To use the cream:
- Make sure your skin is clean and dry before you apply this medicine.
- Apply a thin layer to the affected areas, and gently rub it in.
- When you first begin to use this product, prime the pump by pressing down until the first drop of cream is released.
To use the gel, lotion, or stick:
- Before applying, wash the affected area with a nonmedicated soap and water or with a mild cleanser and then gently pat dry with a towel.
- Apply enough medicine to cover the affected areas, and rub in gently.
To use the shave cream:
- Wet the area to be shaved.
- Apply a small amount of the shave cream and gently rub over entire area.
- Shave. Rinse the area and pat dry.
- After-shave lotions or other drying face products should not be used without checking with your doctor first.
To use the cleansing bar, cleansing lotion, or soap:
- Use to wash the affected areas as directed.
To use the facial mask:
- Before applying, wash the affected area with a nonmedicated cleanser. Then rinse and pat dry.
- Using a circular motion, apply a thin layer of the mask evenly over the affected area.
- Allow the mask to dry for 15 to 25 minutes.
- Then rinse thoroughly with warm water and pat dry.
You should not wash the areas of the skin treated with benzoyl peroxide for at least 1 hour after application.
Avoid getting this medicine in your hair or on colored fabrics. It may bleach your hair or colored fabrics.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For acne:
- For topical dosage form (cleansing bar):
- Adults and children 12 years of age and over—Use 2 or 3 times a day, or as directed by your doctor.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For topical dosage forms (cleansing lotion, cream, or gel):
- Adults and children 12 years of age and over—Use on the affected area(s) of the skin 1 or 2 times a day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For topical dosage form (facial mask):
- Adults and children 12 years of age and over—Use once a week or as directed by your doctor.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For topical dosage form (lotion):
- Adults and children 12 years of age and over—Use on the affected area(s) of the skin 1 to 4 times a day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For topical dosage form (stick):
- Adults and children 12 years of age and over—Use on the affected area(s) of the skin 1 to 3 times a day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For topical dosage form (cleansing bar):
- For inflammatory lesions caused by rosacea:
- For topical dosage form (cream):
- Adults—Apply to the affected area of the skin once a day.
- Children—Use and dose must be determined by your doctor.
- For topical dosage form (cream):
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away any unused Epsolay® topical cream 30 days after first use.
Precautions
It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to check for any unwanted effects.
For patients using the Epsolay® topical cream:
- This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, or unusual tiredness or weakness.
- Serious skin reactions (eg, skin irritation, contact dermatitis) including pain, irritation, itching, burning, redness, peeling, dryness, scaling, or stinging of the skin can occur during treatment with this medicine. Your doctor may tell you to use a moisturizer to treat skin irritation.
- This medicine may make your skin more sensitive to sunlight. Use a sunscreen and wear loose-fitting clothes when you are outdoors. Avoid sunlamps and tanning beds.
During the first 3 weeks you are using benzoyl peroxide, your skin may become irritated. Also, your acne may seem to get worse before it gets better. If your skin problem has not improved within 4 to 6 weeks, check with your doctor.
Certain over-the-counter (OTC) acne products may cause rare and life-threatening allergic reactions. Check with your doctor right away if you have hives, itching, trouble breathing, swelling of the eyes, face, lips, or tongue, tightness in the throat, or feeling faint while using these acne products.
Do not use an OTC acne product again if you have developed a serious allergic reaction from it.
Avoid using any other topical medicine on the same area within 1 hour before or after using benzoyl peroxide. Otherwise, benzoyl peroxide may not work properly.
Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as benzoyl peroxide:
- Any other topical acne product or skin product containing a peeling agent (eg, resorcinol, salicylic acid, sulfur, or tretinoin);
- Hair products that are irritating, such as permanents or hair removal products;
- Skin products that cause sensitivity to the sun, such as those containing lime or spices;
- Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions; or
- Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.
Using these products along with benzoyl peroxide may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it doesn't cause a problem with any other topical products that you might use during the day. Check with your doctor before using any other topical medicines with benzoyl peroxide.
Check with your doctor at any time your skin becomes too dry or irritated. Your doctor can help you choose the right skin products for you to reduce skin dryness and irritation.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Pain, burning, blistering, changes in color, dryness, itching, peeling, redness, scaling, stinging, or swelling of the skin where the medicine is applied
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- dizziness
- fainting
- fast heartbeat
- hives, itching, or skin rash
- increased sensitivity of the skin to sunlight
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- redness or other discoloration of the skin
- severe sunburn
- swelling of the eyes, face, lips, or tongue
- tightness in the throat
- trouble breathing
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Dryness or peeling of the skin (may occur after a few days)
- feeling of warmth, mild stinging, and redness of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062425
