Drugs Details

Drugs Info of Zoderm
Drugs Details
  • Drugs Type  : Multum
  • Date : 17th Jul 2015 07:33 am
  • Brand Name : Zoderm
  • Generic Name : benzoyl peroxide and urea topical (Pronunciation: BEN zoe ill per OX ide and you REE ah)
Descriptions

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ is intended for topical administration and contains Benzoyl Peroxide for use in the treatment of acne vulgaris. Benzoyl Peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure:

 

ZODERM® 
  (Benzoyl Peroxide) Structural Formula Illustration

 

Each mL of ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ contains 57.5 mg of benzoyl peroxide in an emulsion-based formulation consisting of: purified water,urea(100/o),sodium lauryl sulfoacetate, glycerin, propylene glycol, magnesium aluminum silicate, disodium oleamido MEA-sulfosuccinate, sodium octoxynol-2 ethane sulfonate, cetyl alcohol, laureth-12, glyceryl stearate/PEG-100 stearate, xanthan gum, citric acid, sodium citrate, carbomer and disodium EDTA.

 

What are the possible side effects of benzoyl peroxide and urea topical (Zoderm)?

Serious side effects are not likely to occur. Stop using benzoyl peroxide and urea topical and seek emergency medical attention if you experience a rare but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

Some skin burning, stinging, tingling, itching, redness, dryness, peeling, or irritation of the treated area may be experienced while using benzoyl peroxide and urea topical. Contact your doctor if these side effects are excessive. Less frequent application of benzoyl peroxide and urea...

Read All Potential Side Effects and See Pictures of Zoderm »

Indications

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ is indicated for the topical treatment of acne vulgaris.

Dosage Administration

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™

Wash affected areas once or twice a day, or as directed by your dermatologist. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If excessive drying occurs, it may be controlled by rinsing off hydrating wash sooner or using less often.

How Supplied

ZoDerm® 5.75% Benzoyl Peroxide Hydrating Wash™ is supplied in 473 mL bottles, NDC 10337-758-51.

Store at controlled room temperature 15°-25° C (59°-77° F). Protect from freezing.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for: DERM/arts., Division Doak Dermatologics A Subsidiary Of Bradley Pharmaceuticals, Inc. 383 Route 46 West Fairfield, NJ 07004-2402, USA. www.doakderm.com. Manufactured by: Groupe Parima, Inc. Montreal, QC H4S 1X6 CANADA.

Side Effects

Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy.

Interactions

No information provided.

Warnings

When using this product, avoid unnecessary sun exposure and use a sunscreen.

Precautions

General

For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Data from several studies employing a strain of mice that is highly susceptible to developing cancer suggest that Benzoyl Peroxide acts as a tu mor promoter. The clinical significance of these findings to humans is unknown. Benzoyl Peroxide has not been found to be mutagenic (Ames Test) and thereare no published data indicating it impairs fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Benzoyl Peroxide. It is not known whether Benzoyl Peroxide can cause fetal harm when administered to apregnant woman or can affect reproduction capacity. Benzoyl Peroxide should be used by a pregnant woman only if clearly needed. There are no available data on theeffect of Benzoyl Peroxide on the later growth, development and functional maturation of the unborn child.

Nursing Mothers

It is not known whether this drug is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Benzoyl Peroxide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

OverDose

If excessive scaling, erythema or edema occurs, the use of this preparation should be discontinued.Tohasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

ContrainDications

This preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

Clinical Pharamacology

The mechanism of action of Benzoyl Peroxide is not totally understood but itsantibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patientstreated with Benzoyl Peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions.

Little is known about the percutaneous penetration, metabolism, and excretion of Benzoyl Peroxide, although it has been shown that Benzoyl Peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans.

Patient Information

Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops.discontinue use and consult your physician.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Zoderm

Generic Name: benzoyl peroxide and urea topical (Pronunciation: BEN zoe ill per OX ide and you REE ah)

  • What is benzoyl peroxide and urea topical (Zoderm)?
  • What are the possible side effects of benzoyl peroxide and urea topical (Zoderm)?
  • What is the most important information I should know about benzoyl peroxide and urea topical (Zoderm)?
  • What should I discuss with my healthcare provider before using benzoyl peroxide and urea topical (Zoderm)?
  • How should I use benzoyl peroxide and urea topical (Zoderm)?
  • What happens if I miss a dose (Zoderm)?
  • What happens if I overdose (Zoderm)?
  • What should I avoid while using benzoyl peroxide and urea topical (Zoderm)?
  • What other drugs will affect benzoyl peroxide and urea topical (Zoderm)?
  • Where can I get more information?

What is benzoyl peroxide and urea topical (Zoderm)?

 

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away.

Urea is an emollient (skin softening agent). Urea helps to moisturize the skin.

Benzoyl peroxide and urea topical is used to treat acne.

Benzoyl peroxide and urea topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of benzoyl peroxide and urea topical (Zoderm)?

 

Serious side effects are not likely to occur. Stop using benzoyl peroxide and urea topical and seek emergency medical attention if you experience a rare but serious allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives).

Some skin burning, stinging, tingling, itching, redness, dryness, peeling, or irritation of the treated area may be experienced while using benzoyl peroxide and urea topical. Contact your doctor if these side effects are excessive. Less frequent application of benzoyl peroxide and urea topical may be necessary.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Zoderm (5.75 benzoyl peroxide) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about benzoyl peroxide and urea topical (Zoderm)?

 

When applying benzoyl peroxide and urea topical, avoid the eyes, the inside of the nose and mouth, the lips, and areas of broken skin to prevent excessive irritation. If you get medication on any of these areas, rinse it off with water.

Do not use benzoyl peroxide and urea topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions worse. Also avoid using benzoyl peroxide and urea topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Benzoyl peroxide and urea topical may increase the sensitivity of the skin to sunlight. Avoid prolonged exposure to sunlight or artificial UV light (e.g., sunlamps). Use a sunscreen on treated areas while using benzoyl peroxide and urea topical.

Avoid combining sunscreen containing PABA and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.

Avoid contact with clothing and hair. Benzoyl peroxide and urea topical may cause bleaching.

Patient Detailed How Take

What should I discuss with my healthcare provider before using benzoyl peroxide and urea topical (Zoderm)?

 

Do not use benzoyl peroxide and urea topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions worse. Also avoid using benzoyl peroxide and urea topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use benzoyl peroxide and urea topical during treatment with tretinoin (Altinac, Avita, Renova, Retin-A), except under the direction of your doctor. The combination could lead to severe skin irritation.

Benzoyl peroxide and urea topical is in the FDA pregnancy category C. This means that it is not known whether benzoyl peroxide and urea topical will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether benzoyl peroxide passes into breast milk. Do not use benzoyl peroxide and urea topical without first talking to your doctor if you are breast-feeding a baby.

How should I use benzoyl peroxide and urea topical (Zoderm)?

 

Use benzoyl peroxide and urea topical exactly as directed by your doctor, or follow the instructions on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the cleanser, wet the skin and apply the cleanser to the affected area. Massage the medication gently into the skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.

Wash your hands before and after application of the cream or gel.

Before using the cream or gel, clean and dry the affected area using a mild cleanser and water. Apply the medication to the affected area.

When applying benzoyl peroxide and urea topical, avoid the eyes, the inside of the nose and mouth, the lips, and areas where the skin is broken to prevent excessive irritation. If you get medication on any of these areas, rinse it off with water.

Do not use benzoyl peroxide and urea topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions worse. Also avoid using benzoyl peroxide and urea topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not cover the affected area after applying benzoyl peroxide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

Benzoyl peroxide and urea topical is usually applied once or twice daily. Follow your doctor's instructions.

Contact your doctor if you experience excessive skin burning, dryness, or irritation. Less frequent administration of the medication may be necessary.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

It is important to use benzoyl peroxide and urea topical regularly to get the most benefit.

It may take several weeks or more to see the effects of this drug. Do not stop using benzoyl peroxide and urea topical if you do not see results immediately.

Store benzoyl peroxide and urea topical at room temperature away from moisture and heat.

Patient Detailed Avoid Taking

What happens if I miss a dose (Zoderm)?

 

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose.

What happens if I overdose (Zoderm)?

 

An overdose of benzoyl peroxide and urea topical is unlikely to threaten life. If an overdose is suspected, or if benzoyl peroxide and urea topical has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using benzoyl peroxide and urea topical (Zoderm)?

 

Do not use benzoyl peroxide and urea topical on sunburned, windburned, dry, chapped, or irritated skin. It could make these conditions worse. Also avoid using benzoyl peroxide and urea topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Do not use other topical products on the same area at the same time unless directed to do so by your doctor. Other products may interfere with the effects or absorption of benzoyl peroxide and urea topical.

Do not cover the area after applying benzoyl peroxide and urea topical, unless otherwise directed by your doctor. Doing so could cause too much medicine to be absorbed by the body and could be harmful.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area being treated.

Avoid contact with clothing and hair. Benzoyl peroxide may cause bleaching.

Benzoyl peroxide and urea topical may increase the sensitivity of the skin to sunlight. Avoid prolonged exposure to sunlight or artificial UV light (e.g., sunlamps). Use a sunscreen on treated areas while using benzoyl peroxide and urea topical.

Avoid combining sunscreen containing PABA and benzoyl peroxide. Temporary skin discoloration may occur if they are used together.

What other drugs will affect benzoyl peroxide and urea topical (Zoderm)?

 

Do not use benzoyl peroxide and urea topical during treatment with tretinoin (Altinac, Avita, Renova, Retin-A), unless otherwise directed by your doctor. The combination could lead to severe skin irritation.

Do not use other topical products on the same area at the same time unless directed to do so by your doctor. Other products may interfere with the effects or absorption of benzoyl peroxide and urea topical.

Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics on the area being treated.

Drugs other than those listed here may also interact with benzoyl peroxide and urea topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

 

Your pharmacist has additional information about benzoyl peroxide and urea topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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