Dealing with a Lice Outbreak? Get the Best Treatment Now.

Benzoyl Peroxide (Topical)


VA CLASSIFICATION
Primary: DE752
Secondary: DE500

Commonly used brand name(s): 10 Benzagel; 10 Benzagel Acne Gel; 2.5 Benzagel Acne Gel; 2.5 Benzagel Acne Lotion; 5 Benzagel; 5 Benzagel Acne Gel; 5 Benzagel Acne Lotion; 5 Benzagel Acne Wash; 5 Benzagel Liquid Acne Soap; Acetoxyl 10 Gel; Acetoxyl 2.5 Gel; Acetoxyl 20 Gel; Acetoxyl 5 Gel; Acne-Aid Aqua Gel; Acne-Aid Vanishing Cream; Acnomel B.P. 5 Lotion; Ambi 10 Acne Medication; Benoxyl 10 Lotion; Benoxyl 20 Lotion; Benoxyl 5 Lotion; BenzaShave 10 Cream; BenzaShave 5 Cream; Benzac 10 Gel; Benzac 5 Gel; Benzac AC 10 Gel; Benzac AC 21/2 Gel; Benzac AC 5 Gel; Benzac AC Wash 10; Benzac AC Wash 21/2; Benzac AC Wash 5; Benzac W 10 Gel; Benzac W 10 Gel; Benzac W 21/2 Gel; Benzac W 5 Gel; Benzac W 5 Gel; Benzac W Wash 10; Benzac W Wash 5; Brevoxyl-4 Cleansing Lotion; Brevoxyl-4 Gel; Brevoxyl-8 Cleansing Lotion; Brevoxyl-8 Gel; Clean & Clear Persagel 10; Clean & Clear Persagel 5; Clear By Design 2.5 Gel; Clearasil BP Plus 5 Lotion; Clearasil BP Plus Skin Tone Cream; Clearasil Maximum Strength Medicated Anti-Acne 10 Tinted Cream; Clearasil Maximum Strength Medicated Anti-Acne 10 Vanishing Cream; Clearasil Maximum Strength Medicated Anti-Acne 10 Vanishing Lotion; Clearplex 10; Clearplex 5; Cuticura Acne 5 Cream; Del-Aqua-10 Gel; Del-Aqua-5 Gel; Dermacne; Dermoxyl 10 Gel; Dermoxyl 20 Gel; Dermoxyl 5 Gel; Dermoxyl Aqua 5 Gel; Desquam-E 10 Gel; Desquam-E 2.5 Gel; Desquam-E 5 Gel; Desquam-X 10 Bar; Desquam-X 10 Gel; Desquam-X 10 Wash; Desquam-X 2.5 Gel; Desquam-X 5 Gel; Desquam-X 5 Wash; Exact 5 Tinted Cream; Exact 5 Vanishing Cream; Fostex 10 BPO Gel; Fostex 10 Bar; Fostex 10 Cream; Fostex 10 Wash; Fostex 5 Gel; HOxyl 10 Gel; HOxyl 2.5 Gel; HOxyl 20 Gel; HOxyl 5 Gel; Loroxide 5 Lotion; Loroxide 5.5 Lotion; Neutrogena Acne Mask 5; Noxzema Clear-ups Maximum Strength 10 Lotion; Noxzema Clear-ups On-The-Spot 10 Lotion; Oxy 10 Balance Emergency Spot Treatment Cover-Up Formula Gel; Oxy 10 Balance Emergency Spot Treatment Invisible Formula Gel; Oxy 10 Balance Maximum Medicated Face Wash; Oxy 5 Regular Strength Cover-Up Cream; Oxy 5 Regular Strength Vanishing Lotion; Oxy 5 Sensitive Skin Vanishing Lotion; Oxy Balance Deep Action Night Formula Lotion; Oxy Balance Emergency Spot Treatment Invisible Formula; Oxyderm 10 Lotion; Oxyderm 20 Lotion; Oxyderm 5 Lotion; PanOxyl 10 Bar; PanOxyl 10 Gel; PanOxyl 10 Wash; PanOxyl 15 Gel; PanOxyl 20 Gel; PanOxyl 5 Bar; PanOxyl 5 Gel; PanOxyl 5 Wash; PanOxyl AQ 10 Gel; PanOxyl AQ 21/2 Gel; PanOxyl AQ 5 Gel; PanOxyl Aquagel 10; PanOxyl Aquagel 2.5; PanOxyl Aquagel 20; PanOxyl Aquagel 5; Solugel 4; Solugel 8; Student's Choice Acne Medication; Triaz; Triaz Cleanser; Xerac BP 5.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiacne agent (topical)—

keratolytic (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Acne vulgaris(treatment)—Indicated for the topical treatment of mild to moderate acne vulgaris {20}. In more severe acne, benzoyl peroxide may be indicated as an adjunct in therapeutic regimens including oral and topical antibiotics, retinoic acid preparations, and sulfur/salicylic acid–containing preparations. {03} {04} {05} {07} {08} {09} {11} {13}

[Ulcer, decubital (treatment)] or
[Ulcer, stasis (treatment)]—Benzoyl peroxide, usually in a 20% strength, is used as an oxidizing agent in the treatment of decubital or stasis ulcers {40}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    242.23 (hydrous) {02}

Mechanism of action/Effect:

Benzoyl peroxide slowly releases active oxygen. {03} {06}

Acne vulgaris—Benzoyl peroxide has antibacterial action against Propionibacterium acnes {11} in treatment of acne vulgaris {20}. Benzoyl peroxide improves both inflammatory and noninflammatory lesions of acne {13} {14} {15} {20}. The medication also has some keratolytic effect, which produces comedo lysis, as well as drying and desquamative actions that contribute to its efficacy {03} {06}.

Decubital or statis ulcers—Benzoyl peroxide stimulates epithelial cell proliferation and the production of granulation tissue in treatment of decubital or stasis ulcers {40}.

Absorption:

Absorbed by the skin {19}.

Biotransformation:

Metabolized in skin to benzoic acid. About 5% of the metabolized medication is systemically absorbed and eliminated unchanged in the urine {19}.

Onset of action:

Improvement in condition is usually noticeable within 4 to 6 weeks.

Elimination:
    Renal; excreted as benzoic acid in urine {19}.


Precautions to Consider

Carcinogenicity/Tumorigenicity

Benzoyl peroxide is not considered to be a carcinogen and does not show tumor-initiating ability; however, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter {16} {17} {18}.

Pregnancy/Reproduction

Pregnancy—
This medicine may be systemically absorbed {19}.

Studies have not been done in humans or animals {19}.

FDA Pregnancy Category C {42}.

Breast-feeding

It is not known whether benzoyl peroxide is distributed into breast milk {42}. Problems in humans have not been documented; however, benzoyl peroxide may be systemically absorbed {19}.

Pediatrics

Children up to 12 years of age—Appropriate studies on the relationship of age to the effects of benzoyl peroxide have not been performed in this age group. Safety and efficacy have not been established {42}.

Children 12 years of age and over—Pediatrics-specific problems that would limit the usefulness of this medication in this age group are not expected {42}.


Geriatrics


Appropriate studies on the relationship of age to the effects of benzoyl peroxide have not been performed in the geriatric population. However, geriatrics-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Acne products, topical, or products containing a peeling agent, such as
Resorcinol
Salicylic acid
Sulfur
Alcohol-containing products, topical, such as
After-shave lotions
Astringents
Cosmetics or soaps with a strong drying effect
Shaving creams or lotions or
Hair products, skin-irritating, such as hair permanents or hair removal products or
Isotretinoin or
Products containing lime or spices, topical or
Soaps or cleansers, abrasive    (concurrent use with benzoyl peroxide on the same area of the skin may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin. If irritation occurs, the strength or dose of benzoyl peroxide may need to be reduced or application temporarily discontinued until the skin is less sensitive)


Antibiotics, topical, such as clindamycin or erthyromycin or
Retinoids, topical, such as adapalene or tretinoin    (although these medications are used in a treatment regimen with benzoyl peroxide for therapeutic effect, their use on the same area of the skin at the same time is not recommended. The oxidizing action of benzoyl peroxide degrades antibiotics over time. A physical incompatibility between the use of the medications and benzoyl peroxide or a change in pH may reduce their efficacy if used simultaneously. When used together for clinical effect, it is recommended that these medications and benzoyl peroxide be used at different times of the day, such as morning and night, to minimize possible skin irritation, unless otherwise directed. If irritation occurs, changes in dose or frequency may be needed until the skin is less sensitive {11} {12})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Dermatitis, seborrheic or
Eczema or
» Inflammation of skin, acute, or denuded skin, including sunburn    (irritation may be increased; benzoyl peroxide should be discontinued until the skin is less sensitive {40})


Sensitivity to benzoyl peroxide or parabens{14}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Allergic contact dermatitis {14}(burning, blistering, crusting, itching, severe redness, or swelling of skin)
    
irritant effect {09}{14}{20}{22}(painful irritation of skin)
    
skin rash {40}



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Dryness or peeling of skin —may occur after a few days{06}{20}{22}
    
feeling of warmth, mild stinging, or redness of skin
{06}{20}{22}




Overdose
For specific information on the agents used in the management of benzoyl peroxide overdose, see:
   • Corticosteroids (Topical) monograph {10}.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Burning, itching, scaling, redness, or swelling of skin, severe{10}


Treatment of overdose
Medication should be discontinued. After symptoms and signs of overdosage subside, a reduced dosage schedule may be cautiously reinstated {40}.

Specific treatment—Emollients, cool compresses, and/or topical corticosteroid preparations may be used to hasten resolution of overdosage {40}.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Benzoyl Peroxide (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to benzoyl peroxide or to parabens
Other medical problems, especially acute inflammation of skin or denuded skin, including sunburn

Proper use of this medication
» Importance of not using more medication than the amount recommended

» Avoiding contact with the eyes, mucous membranes, and sensitive areas of the neck

» Not applying medication to raw or irritated skin, including windburned or sunburned skin, or, unless told otherwise, to open wounds

Reading patient directions carefully before use

Proper administration

For cream, gel, lotion, or stick dosage form
Before applying—Washing affected area with nonmedicated soap and water or with a mild cleanser; gently patting dry

Applying enough medication to cover affected area and rubbing in gently

For shave cream dosage form
Wetting area to be shaved; applying a small amount and gently rubbing over entire area; shaving; rinsing area and patting dry; not using after-shave lotions or other drying face products without checking with physician

For cleansing bar or lotion or soap dosage form
Using to wash affected areas

For facial mask dosage form
Before applying—Washing affected area with nonmedicated cleanser; rinsing and patting skin dry

Using circular motion, applying thin layer of mask evenly over affected area

Allowing mask to dry for 15 to 25 minutes

Rinsing thoroughly with warm water and patting dry
Washing hands afterwards to remove any lingering medication

» Proper dosing
Missed dose: Applying as soon as possible

» Proper storage

Precautions while using this medication
Possibility that skin will become irritated or that acne may appear to worsen during the first 3 weeks of therapy; checking with health care professional if skin problem has not improved within 4 to 6 weeks

Not washing the areas of the skin treated with benzoyl peroxide for at least 1 hour after application

» Avoiding use of any other topical product on the same area within 1 hour before or after application of benzoyl peroxide to avoid physical incompatibilities or excessive skin irritation

Either checking with health care professional before using or avoiding use of other topical acne or skin products containing a peeling agent (resorcinol, salicylic acid, sulfur, or tretinoin), irritating hair products (permanents or hair removal products), sun-sensitizing skin products (could contain lime or spices), alcohol-containing skin products, or drying or abrasive skin products (some cosmetics or soaps or skin cleansers); sometimes benzoyl peroxide is used with topical antibiotics or topical tretinoin but medication is applied at different times of the day to lessen skin irritation

» Medication may bleach hair or colored fabrics

Checking with doctor any time skin becomes too dry or too irritated; choosing proper skin products to reduce skin dryness or irritation


Side/adverse effects
Signs of potential side effects, especially allergic contact dermatitis, irritant effect, or skin rash


General Dosing Information
This medication contains an oxidizing agent that may bleach hair and colored fabrics {40}.


For treatment of acne
   • Benzoyl peroxide should not be applied to acutely inflamed, denuded, or highly sensitive skin, unless otherwise directed by physician as in treating an ulceration.
   • Therapy may be initiated with the 2.5 or 5% cream, gel, or lotion, then changed to the 10% strength after 3 to 4 weeks, if needed, or sooner if tolerance to the lower strengths has been determined {20}.
   • After treatment with benzoyl peroxide for approximately 8 to 12 weeks, maximum lesion reduction may be expected {30}. Continued prophylactic use of benzoyl peroxide is usually required to maintain optimal therapeutic response {09}.
   • In fair-skinned patients or under excessively dry atmospheric conditions, it is recommended that therapy be initiated with one application daily and gradually increased up to 2 to 4 times a day (depending on the dosage form) as tolerated.



For treatment of decubital or stasis ulcers
   • A protective ointment should be applied to a wide area bordering the ulcer to decrease the possibility of irritant dermatosis of the surrounding skin {40}.
   • Ulcers should be treated by applying a sterile dressing of terry cloth moistened with normal saline and saturated with 20% lotion to the clean and surgically debrided ulcer. Occlude the dressed area with a plastic film and apply an abdominal dressing pad overall and tape firmly in place. Change the dressing every 8 hours in large ulcers and every 12 hours in small ulcers. {40}
   • For maximal therapeutic efficacy, the lotion dressing should be kept moist and as close to 37 °C (98.6 °F) as possible: the plastic film is used to retain moisture and the abdominal dressing pad is used to increase the local temperature through its insulating effect {40}.
   • Exuberant granulation tissue may be kept below the epidermal level with cauterization by a silver nitrate stick to facilitate ingrowth of epithelium {40}.
   • Severe ulcers may be treated by packing with surgical gauze saturated with 20% lotion to facilitate good contact with the walls of the cavity and then occluding {40}.
   • Large amounts of serous exudate appearing on the ulcer surface is a normal response to benzoyl peroxide therapy {40}.
   • Two weeks may pass before progress is visible in large chronic ulcers {40}.



Topical Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

BENZOYL PEROXIDE CLEANSING BAR

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 5 or 10% cleansing bar two or three times a day or as directed.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—


5% (OTC) [PanOxyl 5 Bar{23}]


10% (OTC) [Desquam-X 10 Bar{24}] [Fostex 10 Bar{23}] [PanOxyl 10 Bar{23}]

Canada—


5% (OTC) [PanOxyl 5 Bar{25}]


10% (Rx) [PanOxyl 10 Bar{25}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.


BENZOYL PEROXIDE CLEANSING LOTION

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 5 to 10% cleansing lotion one or two times a day.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


21/2% (Rx) [Benzac AC Wash 21/2{28}][Generic]


4% (Rx) [Brevoxyl-4 Cleansing Lotion{30} (cetyl alcohol)]


5% [Benzac AC Wash 5 (Rx){28}] [Benzac W Wash 5 (Rx){28}] [Desquam-X 5 Wash (Rx){31}][Generic]


8% (Rx) [Brevoxyl-8 Cleansing Lotion{30} (cetyl alcohol)]


10% [Benzac AC Wash 10 (Rx){28}] [Benzac W Wash 10 (Rx){28}] [Desquam-X 10 Wash (Rx){31}] [Fostex 10 Wash (OTC){23}] [Oxy 10 Balance Maximum Medicated Face Wash (OTC)] [Triaz Cleanser (Rx){36}][Generic]

Canada—


5% [Benzac W Wash 5 (OTC){29}] [5 Benzagel Acne Wash (OTC) (cetyl alcohol) (methylparaben) (paraben){32}] [5 Benzagel Liquid Acne Soap (OTC)] [Desquam-X 5 Wash (Rx){32}] [PanOxyl 5 Wash (Rx){25} (parabens)]


10% (Rx) [Benzac W Wash 10{29}] [Desquam-X 10 Wash{32}] [PanOxyl 10 Wash{25} (parabens)]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only.

Note: Benzac W does not require shaking.



BENZOYL PEROXIDE CREAM

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 5 to 10% cream one or two times a day.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


5% [BenzaShave 5 Cream (Rx) (methylparaben) (propylparaben){27}] [Cuticura Acne 5 Cream (OTC){23}] [Exact 5 Tinted Cream (OTC) (parabens){23}] [Exact 5 Vanishing Cream (OTC) (parabens){23}]


10% [Ambi 10 Acne Medication (OTC) (parabens){23}] [Acne-Aid Vanishing Cream (OTC) (methylparaben) (propylparaben){26}] [BenzaShave 10 Cream (Rx) (methylparaben) (propylparaben){27}] [Clearasil Maximum Strength Medicated Anti-Acne 10 Tinted Cream (OTC) (methylparaben) (propylparaben)] [Clearasil Maximum Strength Medicated Anti-Acne 10 Vanishing Cream (OTC)] [Fostex 10 Cream (OTC) (methylparaben) (propylparaben){23}]

Canada—


5% (OTC) [Clearasil BP Plus Skin Tone Cream] [Oxy 5 Regular Strength Cover-Up Cream]{48}

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


BENZOYL PEROXIDE FACIAL MASK

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 5% facial mask once a week to once a day, or as directed.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—


5% (OTC) [Neutrogena Acne Mask 5{23}]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


BENZOYL PEROXIDE GEL USP

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 2.5 to 20% gel one or two times a day.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


2.5% [Acne-Aid Aqua Gel (OTC){41}] [Benzac AC 21/2 Gel (Rx){28}] [Benzac W 21/2 Gel (Rx){28}] [Clear By Design 2.5 Gel (OTC){23}] [Desquam-E 2.5 Gel (Rx){31}] [Desquam-X 2.5 Gel (Rx){31}] [PanOxyl AQ 21/2 Gel (Rx) (methylparaben){42}][Generic]


4% (Rx) [Brevoxyl-4 Gel (cetyl alcohol) (stearyl alcohol)]


5% [5 Benzagel (Rx){23}] [Benzac AC 5 Gel (Rx){28}] [Benzac 5 Gel (Rx) (alcohol 12%){28}] [Benzac W 5 Gel (Rx){28}] [Clean & Clear Persagel 5 (OTC)] [Clearplex 5] [Del-Aqua-5 Gel{23}] [Desquam-E 5 Gel (Rx){31}] [Desquam-X 5 Gel (Rx){31}] [Fostex 5 Gel (OTC)] [Oxy Balance Emergency Spot Treatment Invisible Formula (OTC)] [PanOxyl AQ 5 Gel (Rx) (methylparaben){42}] [PanOxyl 5 Gel (Rx) (alcohol 20%){42}][Generic]


6% (Rx) [Triaz{36}]


8% (Rx) [Brevoxyl-8 Gel (cetyl alcohol) (stearyl alcohol)]


10% [Benzac AC 10 Gel (Rx){28}] [Benzac 10 Gel (Rx) (alcohol 12%){28}] [Benzac W 10 Gel (Rx){28}] [10 Benzagel (Rx){23}] [Clean & Clear Persagel 10 (OTC)] [Clearplex 10 (OTC)] [Del-Aqua-10 Gel (OTC){23}] [Desquam-E 10 Gel (Rx){31}] [Desquam-X 10 Gel (Rx){31}] [Fostex 10 BPO Gel (OTC){28}] [Oxy 10 Balance Emergency Spot Treatment Cover-Up Formula Gel (OTC)] [Oxy 10 Balance Emergency Spot Treatment Invisible Formula Gel (OTC)] [PanOxyl AQ 10 Gel (Rx) (methylparaben){42}] [PanOxyl 10 Gel (Rx) (alcohol 20%){42}] [Triaz (Rx){36}][Generic]

Canada—


2.5% [Acetoxyl 2.5 Gel (Rx) (acetone){43}] [2.5 Benzagel Acne Gel (OTC) (alcohol 15%){32}] [H2Oxyl 2.5 Gel (Rx){45}] [PanOxyl Aquagel 2.5 (Rx){25}]


4% (Rx) [Solugel 4{47}]


5% [Acetoxyl 5 Gel (Rx) (acetone){43}] [Benzac AC 5 Gel (OTC)] [Benzac W 5 Gel (OTC){29}] [5 Benzagel Acne Gel (OTC) (alcohol 15%){32}] [Dermoxyl Aqua 5 Gel (OTC){44}] [Dermoxyl 5 Gel (OTC) (acetone){44}] [Desquam-X 5 Gel (Rx){32}] [H2Oxyl 5 Gel (Rx){45}] [PanOxyl Aquagel 5 (Rx){25}] [PanOxyl 5 Gel (Rx) (alcohol){25}] [Xerac BP 5 (Rx)]


8% (Rx) [Solugel 8{47}]


10% (Rx) [Acetoxyl 10 Gel (acetone){43}] [Benzac AC 10 Gel] [Benzac W 10 Gel{29}] [10 Benzagel Acne Gel (alcohol 15%){46}] [Dermoxyl 10 Gel (acetone){44}] [Desquam-X 10 Gel{32}] [H2Oxyl 10 Gel{45}] [PanOxyl Aquagel 10{25}] [PanOxyl 10 Gel (alcohol){25}]


15% (Rx) [PanOxyl 15 Gel (alcohol){25}]


20% (Rx) [Acetoxyl 20 Gel (acetone){43}] [Dermoxyl 20 Gel (acetone){44}] [H2Oxyl 20 Gel{45}] [PanOxyl Aquagel 20{25}] [PanOxyl 20 Gel (alcohol){25}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.


BENZOYL PEROXIDE LOTION USP

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 5 to 10% lotion one to four times a day.

[Decubital ulcer] or
[Stasis ulcer]
Topical, to the ulcer, as a 20% lotion every 8 hours for large ulcers and every 12 hours for small ulcers.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose.


Strength(s) usually available
U.S.—


5% (OTC) [Benoxyl 5 Lotion{34}][Generic]


5.5% (OTC) [Loroxide 5.5 Lotion{23}]


10% (OTC) [Benoxyl 10 Lotion (methylparaben) (propylparaben){34}] [Clearasil Maximum Strength Medicated Anti-Acne 10 Vanishing Lotion{23}] [Noxzema Clear-ups Maximum Strength 10 Lotion (methylparaben) (propylparaben)] [Noxzema Clear-ups On-The-Spot 10 Lotion (methylparaben) (propylparaben)] [Oxy Balance Deep Action Night Formula Lotion{23}] [Student's Choice Acne Medication{35}][Generic]

Canada—


2.5% (OTC) [2.5 Benzagel Acne Lotion{32}] [Oxy 5 Sensitive Skin Vanishing Lotion{48}]


5% [Acnomel B.P. 5 Lotion (OTC){37}] [Benoxyl 5 Lotion (Rx){38}] [5 Benzagel Acne Lotion (OTC){32}] [Clearasil BP Plus 5 Lotion (OTC)] [Dermacne (OTC)] [Loroxide 5 Lotion (Rx){39}] [Oxyderm 5 Lotion (Rx){40}] [Oxy 5 Regular Strength Vanishing Lotion (OTC){48}]


10% (Rx) [Benoxyl 10 Lotion{38}] [Oxyderm 10 Lotion{40}]


20% (Rx) [Benoxyl 20 Lotion{38}] [Oxyderm 20 Lotion{40}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Preparation of dosage form:
In some products, benzoyl peroxide powder is packaged separately and must be added to the lotion before dispensing.

Auxiliary labeling:
   • Shake well.
   • For external use only.


BENZOYL PEROXIDE STICK

Usual adult and adolescent dose
Acne vulgaris
Topical, to the skin, as a 10% stick one to three times a day.


Usual pediatric dose
Acne vulgaris
Children up to 12 years of age: Safety and efficacy have not been established.

Children 12 years of age and over: See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—
Not commercially available.

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • For external use only.



Revised: 07/29/1998



References
  1. The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed. (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention Inc; 1994. p. 179-181.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 90.
  1. Bergfeld WF. The evaluation and management of acne: economic considerations. J Am Acad Dermatol 1995; 32(5 Pt 3): S52-S56.
  1. Greenwood R, Burke B, Cunliffe W. Evaluation of a therapeutic strategy for the treatment of acne vulgaris with conventional therapy. Br J Dermatol 1986; 114(3): 353-8.
  1. Hughes BR, Murphy CE, Barnett J, Cunliffe WJ. Strategy of acne therapy with long-term antibiotics. Br J Dermatol 1989; 121(5): 623-8.
  1. Jaffe GV, Grimshaw JJ, Constad D. Benzoyl peroxide in the treatment of acne vulgaris: a double-blind, multi-centre comparative study of Quinoderm cream and Quinoderm cream with hydrocortisone versus their base vehicle alone and a benzoyl peroxide gel preparation. Curr Med Res 1989; 11(7): 453-62.
  1. Nielsen PG. Topical metronidazole gel use in acne vulgaris. Int J Dermatol 1991 Sep; 30(9): 662-6.
  1. Packman AM, Brown RH, Dunlap FE, et al. Treatment of acne vulgaris: combination of 3% erythromycin and 5% benzoyl peroxide in a gel compared to clindamycin phosphate lotion. Int J Dermatol 1996 Mar; 35(3): 209-11.
  1. Marsden JR. Evidence that method of use, dose, and duration of treatment with benzoyl peroxide and tetracycline determines response of acne. J R Soc Med 1985 Supplement; 10(78): 25-8.
  1. Amkraut AA, Jordan WP, Taskovich L. Effect of coadministration of corticosteroids on the development of contact sensitization. J Am Acad Dermatol 1996; 35(1): 27-31.
  1. Lookingbill DP, Chalker DK, Lindholm JS, et al. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations. J Am Acad Dermatol 1997; 37(4): 590-5.
  1. Caron D, Sorba V, Clucas A, et al. Skin tolerance of adapalene 0.1% gel in combination with other topical antiacne treatments. J Am Acad Dermatol 1997; 35(6 Pt 2): S113-S115.
  1. Berson DS, Shalita A. The treatment of acne: the role of combination therapies. J Am Acad Dermatol 1995; 32(5 Pt 3): S113-S115.
  1. Leyden JJ, Shalita AR. Rational therapy for acne vulgaris: an update on topical treatment. J Am Acad Dermatol 1986 Oct; (4 Pt 2): 907-14.
  1. Leyden JJ. New understandings of the pathogenesis of acne. J Am Acad Dermatol 1995; 32(5 Pt 3): S15-S25.
  1. Jones GRN. Skin cancer: risk to individuals using the tumour promoter benzoyl peroxide for acne treatment. Hum Toxicol 1985 Jan; 4(1): 75-8.
  1. Slaga TJ, Fischer SM, Weeks CE, et al. Skin tumour-promoting activity of benzoyl peroxide, a widely used free radical generating compound. Science 1981; 213: 1023-5.
  1. Kraus AL, Munra IC, Orr JC, et al. Benzoyl peroxide: an integrated human safety assessment for carcinogenicity. Regul Toxicol Pharmacol 1995; 21: 87-107.
  1. Rothman KF, Pochi PE. Use of oral and topical agents for acne in pregnancy. J Am Acad Dermatol 1988; 19(3): 431-42.
  1. Mills OH, Kligman AM, Pochi PE, et al. Comparing 2.5%, 5%, and 10% benzoyl peroxide on inflammatory acne vulgaris. Int J Dermatol 1986 Dec; 664-7.
  1. Draelos ZK. Patient compliance: enhancing clinician abilities and strategies. J Am Acad Dermatol 1995 May; 32(5 Pt 3): S31-S41.
  1. Fyrand O, Jakobsen HB. Water-based versus alcohol-based benzoyl peroxide preparations in the treatment of acne vulgaris. Dermatologica 1986; 172(5): 263-7.
  1. Hebel SK, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc. p. 544-5.
  1. Desquam-X 10 Bar package insert (Westwood-Squibb—US), Rev 01/01/90, Rec 05/07/97.
  1. Panoxyl 5% and 10% bars and gel, and 15% and 20% gel (Stiefel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1265.
  1. Acne-Aid Vanishing Cream package insert (Durham—US), Rev 1/95, Rec 03/25/98.
  1. Benzashave package insert (Medicis—US), Rec 04/11/97.
  1. Benzac and Benzac AC package inserts or product packaging (Galderma—US), Rev 3/94, Rec 5/1/97.
  1. Benzac and Benzac AC package inserts or product packaging (Galderma—Canada), Rec 5/22/97.
  1. Brevoxyl package inserts or product packaging (Stiefel—US), Rev 5/96, Rec 4/2/98.
  1. Desquam-X and Desquam-E package inserts or product packaging (Westwood-Squibb—US), Rev 7/90, Rec 3/10/98.
  1. Desquam-X (Westwood-Squibb). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 469.
  1. Benzagel (Novartis Consumer Health). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 185-6.
  1. Benoxyl product packaging (Stiefel—US), Rev 10/96, Rec 4/2/98.
  1. Student's CHOICE package insert and product packaging (Durham—US), Rev 4/94, Rec 3/25/98.
  1. Triaz package insert and product packaging (Medicis—US), Rev 12/96, Rec 4/11/97.
  1. Acnomel B.P. 5 (Chattem). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 21.
  1. Benoxyl (Stiefel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 183.
  1. Loroxide (Dermik Canada). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 905.
  1. Oxyderm product monograph (ICN Canada—Canada), Rev 6/80, Rec 4/18/97.
  1. Acne-Aid Aqua Gel package insert and product packaging (Durham—US), Rev 3/96, Rec 3/25/98.
  1. PanOxyl and PanOxyl AQ package inserts and product packagings (Durham—US), Rev 6/95, Rec 4/2/98.
  1. Acetoxyl (Stiefel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 20.
  1. Dermoxyl product monograph (Gel and Aquagel) (ICN Canada—Canada), Rev 10/93, Rec 4/18/97.
  1. H2Oxyl package inserts and product packagings (Stiefel—Canada), Rec 5/4/89.
  1. 10 Benzagel (Dermik Canada). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 186.
  1. Solugel (Stiefel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 1560.
  1. Oxy 5 product packagings (SK Beecham—Canada), Rec 6/10/98.
  1. Manufacturer phone calls, 6/9/98.
Hide
(web4)