Acetoxyl 10, 2.5, 20, 5

It may also be used for other conditions as determined by your doctor .

Some of these preparations are available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not included in product labeling, benzoyl peroxide is used in certain patients with the following medical conditions:

• Decubital ulcer (bed sores)


• Stasis ulcer (a certain type of ulcer)

This product is available in the following dosage forms:

• Soap


• Lotion


• Solution


• Cream


• Gel/Jelly


• Liquid


• Pad


• Foam

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

For children up to 12 years of age: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of benzoyl peroxide with use in other age groups. For children 12 years of age and older: Although there is no specific information comparing use of benzoyl peroxide in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 12 years of age and older than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of benzoyl peroxide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 or


• Red or raw skin, including sunburned skinaa‚¬a€ťIrritation will occur if benzoyl peroxide is used with these conditions

Proper Use

It is very important that you use this medicine only as directed . Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor . To do so may cause irritation of the skin .

Do not use this medicine in or around the eyes or lips, or inside the nose, or on sensitive areas of the neck . Spread the medicine away from these areas when applying. If the medicine gets on these areas, wash with water at once.

Do not apply this medicine to windburned or sunburned skin or on open wounds, unless otherwise directed by your doctor .

This medicine usually comes with patient directions. Read them carefully before using the medicine.

To use the cream, gel, lotion, or stick form of benzoyl peroxide:

• Before applying, wash the affected area with 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 form of benzoyl peroxide:

• 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 form of benzoyl peroxide:

• Use to wash the affected areas as directed .

To use the facial mask form of benzoyl peroxide:

• 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.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

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 cleansing bar dosage form:
    
    
    
    • Adults and children 12 years of age and overaa‚¬a€ťUse two or three times a day, or as directed by your doctor .
    
    
    • Children up to 12 years of ageaa‚¬a€ťUse and dose must be determined by your doctor .
    
    
    
    
  
  
  • For cleansing lotion, cream, or gel dosage forms:
    
    
    
    • Adults and children 12 years of age and overaa‚¬a€ťUse on the affected area(s) of the skin one or two times a day.
    
    
    • Children up to 12 years of ageaa‚¬a€ťUse and dose must be determined by your doctor .
    
    
    
    
  
  
  • For lotion dosage form:
    
    
    
    • Adults and children 12 years of age and overaa‚¬a€ťUse on the affected area(s) of the skin one to four times a day.
    
    
    • Children up to 12 years of ageaa‚¬a€ťUse and dose must be determined by your doctor .
    
    
    
    
  
  
  • For facial mask dosage form:
    
    
    
    • Adults and children 12 years of age and overaa‚¬a€ťUse one time a week or as directed by your doctor .
    
    
    • Children up to 12 years of ageaa‚¬a€ťUse and dose must be determined by your doctor .
    
    
    
    
  
  
  • For stick dosage form:
    
    
    
    • Adults and children 12 years of age and overaa‚¬a€ťUse on the affected area(s) of the skin one to three times a day.
    
    
    • Children up to 12 years of ageaa‚¬a€ťUse and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

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.

Precautions

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 health care professional .

You should not wash the areas of the skin treated with benzoyl peroxide for at least 1 hour after application.

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 (such as 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.

This medicine may bleach hair or colored fabrics.

Check with your doctor at any time your skin becomes too dry or irritated. Your health care professional 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling


• Skin rash

Symptoms of overdose

• Burning, itching, scaling, redness, or swelling of skin (severe)

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 skin (may occur after a few days)


• Feeling of warmth, mild stinging, and redness of 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.