Benzagel Topical

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

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

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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 skin—Skin irritation will occur if benzoyl peroxide is used in patients with these conditions.

This section provides information on the proper use of a number of products that contain benzoyl peroxide. It may not be specific to Benzagel. Please read with care.

Use this medicine only as directed by your doctor. 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.

This medicine is for use only on 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.

This medicine usually comes with patient directions. Read the instructions carefully. Ask your doctor if you have any questions.

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.

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

To use the cream, 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.

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

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

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 two or three 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 one or two 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 one to four 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 one to three times a day.
    • Children younger than 12 years of age—Use 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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:

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

• Difficult breathing
• fainting
• hives
• itching
• swelling of the eyes, face, lips, or tongue
• tightness in the throat

Get emergency help immediately if any of the following symptoms of overdose occur:

• 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:

• 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.

Benzoyl peroxide topical is used to treat acne and may be used for other skin conditions as determined by your doctor.

This medicine is available without prescription. Some of the skin products are available only with your doctor's prescription.

Applies to benzoyl peroxide topical: compounding powder, topical bar, topical cream, topical foam, topical gel, topical kit, topical liquid, topical lotion, topical pad, topical soap

Dermatologic

Very common (10% or more): Peeling, application site erythema
Common (1% to 10%): Dryness, pruritus, contact sensitization reactions
Uncommon (0.1% to 1%): Burning sensation
Frequency not reported: Contact dermatitis, application site rash, application site discoloration, application site reactions (irritation and pain)[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions, including application site hypersensitivity and anaphylaxis[Ref]

General

The most commonly reported side effects were peeling and application site erythema.[Ref]

Other

Frequency not reported: Swelling of the face[Ref]

Some side effects of Benzagel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.