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Benzoyl Peroxide

Pronunciation

(BEN zoe il peer OKS ide)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Bar, External:

PanOxyl: 10% (1 ea)

Cream, External:

Clearskin: 10% (30 g)

Foam, External:

BenzEFoam: 5.3% (60 g, 100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]

BenzEFoamUltra: 9.8% (100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]

BenzePrO: 5.3% (60 g, 100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]

BenzePrO Short Contact: 9.8% (100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]

BP Foam: 5.3% (60 g, 100 g); 9.8% (100 g) [contains methylparaben, propylparaben]

Riax: 5.5% (100 g); 9.5% (100 g) [contains methylparaben, propylparaben]

Generic: 5.3% (60 g, 100 g); 9.8% (100 g)

Gel, External:

Acne Medication 5: 5% (42.5 g) [contains edetate disodium]

Acne Medication 10: 10% (42.5 g) [contains edetate disodium]

Acne-Clear: 10% (42.5 g)

Benziq: 5.25% (50 g) [contains benzyl alcohol, disodium edta, trolamine (triethanolamine)]

Benziq LS: 2.75% (50 g) [contains trolamine (triethanolamine)]

BP Gel: 5% (60 g) [contains benzyl alcohol, edetate disodium, trolamine (triethanolamine)]

BP Gel: 5.5% (60 g); 10% (60 g) [contains benzyl alcohol, disodium edta, trolamine (triethanolamine)]

BPO: 4% (42.5 g [DSC]); 8% (42.5 g [DSC]) [contains benzyl alcohol, cetyl alcohol]

Clearplex V: 5% (45 g)

Clearplex X: 10% (45 g)

OC8: 7% (45 g) [contains disodium edta, propylene glycol]

PanOxyl: 3% (10 g) [contains disodium edta]

Generic: 2.5% (60 g); 5% (60 g, 90 g); 10% (56 g, 60 g, 90 g)

Kit, External:

AcneFree Acne Clearing System: Wash 2.5% and lotion 3.7% [contains disodium edta, polysorbate 80, propylene glycol]

AcneFree Severe Clearing Syst: Wash 2.5% and lotion 10% [contains benzalkonium chloride, butylparaben, cetyl alcohol, disodium edta, edetate sodium (tetrasodium), ethylparaben, isobutylparaben, methylisothiazolinone, methylparaben, propylene glycol, propylparaben, soybeans (glycine max)]

Benzoyl Peroxide Wash: Wash 8% (170.1 g) and bar soap 5% (2 x 21 g), Liquid wash 4% (170.1 g) and bar soap 5% (2 x 21 g) [contains cetearyl alcohol, methylparaben]

BPO Creamy Wash: Wash 4% (170.1 g) and bar soap 5% (2 x 21 g), Wash 8% (170.1 g) and bar soap 5% (2 x 21 g) [contains disodium edta, methylparaben]

Inova: Pad 4% (30s) and tocopherol 5% (28s), Pad 8% (30s) and tocopherol 5% (28s) [contains disodium edta, methylparaben]

Lavoclen-4 Acne Wash: 4% [DSC] [soap free; contains butylparaben, cetearyl alcohol, methylparaben, propylparaben]

Lavoclen-4 Acne Wash: 4% [soap free; contains butylparaben, methylparaben, propylparaben]

Lavoclen-8 Acne Wash: 8% [DSC] [soap free; contains butylparaben, cetearyl alcohol, methylparaben, propylparaben]

Lavoclen-8 Acne Wash: 8% [soap free; contains butylparaben, methylparaben, propylparaben]

SE BPO Wash: 7 & 5.5 % [DSC] [contains cetearyl alcohol, cetyl alcohol, disodium edta, glycine soja (soybean) sterol, methylparaben, propylparaben]

Liquid, External:

Benzac AC Wash: 5% (226 g)

Benzac W Wash: 5% (226 g [DSC])

BenzePrO Creamy Wash: 7% (180 g) [contains cetyl alcohol, edetate disodium, propylene glycol]

Benziq Wash: 5.25% (175 g) [contains benzyl alcohol, cetyl alcohol, disodium edta, propylene glycol]

Benzoyl Peroxide Wash: 5% (148 g, 237 g) [contains cetyl alcohol, edetate disodium, propylene glycol]

Benzoyl Peroxide Wash: 5% (142 g, 227 g) [contains edetate disodium]

Benzoyl Peroxide Wash: 10% (148 g, 237 g) [contains cetyl alcohol, edetate disodium, propylene glycol]

Benzoyl Peroxide Wash: 10% (142 g, 227 g) [contains edetate disodium]

BP Cleanser: 4.25% (480 g [DSC]) [contains cetyl alcohol, edetate disodium, propylene glycol]

BP Foaming Wash: 10% (227 g) [contains cetearyl alcohol, methylparaben]

BP Wash: 2.5% (227 g); 5% (113 g, 142 g, 227 g) [contains cetearyl alcohol, methylparaben]

BP Wash: 5.25% (175 g); 7% (473 mL) [contains benzyl alcohol, cetyl alcohol, propylene glycol, trolamine (triethanolamine)]

BP Wash: 10% (142 g, 227 g) [contains cetearyl alcohol, methylparaben]

BPO-10 Wash: 10% (227 g) [contains methylparaben, propylene glycol, propylparaben]

BPO-5 Wash: 5% (227 g) [contains methylparaben, propylene glycol, propylparaben]

Desquam-X Wash: 5% (140 g); 10% (140 g) [contains edetate disodium]

Lavoclen-4 Creamy Wash: 4% (170.1 g [DSC]) [contains cetearyl alcohol, methylparaben]

Lavoclen-8 Creamy Wash: 8% (170.1 g [DSC]) [contains cetearyl alcohol, methylparaben]

Neutrogena Clear Pore: 3.5% (125 mL) [contains disodium edta, menthol]

PanOxyl: 2.5% (156 g) [soap free; contains cetearyl alcohol]

PanOxyl Wash: 10% (156 g) [contains alcohol, usp, methylparaben]

PanOxyl-4 Creamy Wash: 4% (170.1 g) [contains cetearyl alcohol, methylparaben]

PanOxyl-8 Creamy Wash: 8% (170.1 g [DSC]) [contains cetearyl alcohol, methylparaben]

PR Benzoyl Peroxide Wash: 7% (180 g, 473 mL) [contains cetyl alcohol, edetate disodium, propylene glycol]

SE BPO Wash: 7% (180 g [DSC]) [contains edetate disodium, methylparaben]

TL BPO MX Cleanser: 4.25% (480 mL [DSC]) [contains cetyl alcohol, edetate disodium, propylene glycol]

Liquid Extended Release, External:

Advanced Acne Wash: 4.4% (104 mL)

Lotion, External:

Acne Medication 5: 5% (29.5 mL, 30 mL [DSC]) [odorless; contains disodium edta]

Acne Medication: 10% (30 mL [DSC]) [odorless; contains edetate disodium]

Acne Medication 10: 10% (29.5 mL) [odorless; contains edetate disodium]

Benzoyl Peroxide Cleanser: 3% (340.2 g); 6% (170.3 g, 340.2 g) [contains cetyl alcohol, edetate disodium, propylene glycol]

Benzoyl Peroxide Cleanser: 6% (170.3 g [DSC], 340.2 g [DSC]) [contains menthol, trolamine (triethanolamine)]

Benzoyl Peroxide Cleanser: 9% (340.2 g) [contains cetyl alcohol, edetate disodium, propylene glycol]

Benzoyl Peroxide Cleanser: 9% (170.3 g [DSC], 340.2 g [DSC]) [contains menthol, trolamine (triethanolamine)]

BP Cleansing: 4% (297 g) [contains cetyl alcohol, propylene glycol]

Oscion Cleanser: 6% (170.3 g, 340.2 g)

Zaclir Cleansing: 8% (297 g)

Miscellaneous, External:

BenzePrO Foaming Cloths: 6% (60 ea) [contains cetyl alcohol]

BPO Foaming Cloths: 3% (60 ea [DSC]); 6% (60 ea); 9% (60 ea [DSC]) [contains methylparaben]

SE BPO Foaming Cloths: 3% (1 ea [DSC], 60 ea [DSC]); 6% (1 ea [DSC], 60 ea [DSC]); 9% (1 ea [DSC], 60 ea [DSC]) [contains cetyl alcohol]

Brand Names: U.S.

  • Acne Medication 10 [OTC]
  • Acne Medication 5 [OTC]
  • Acne Medication [OTC] [DSC]
  • Acne-Clear [OTC]
  • AcneFree Acne Clearing System [OTC]
  • AcneFree Severe Clearing Syst [OTC]
  • Advanced Acne Wash [OTC]
  • Benzac AC Wash
  • Benzac W Wash [DSC]
  • BenzEFoam
  • BenzEFoamUltra
  • BenzePrO
  • BenzePrO Creamy Wash
  • BenzePrO Foaming Cloths
  • BenzePrO Short Contact
  • Benziq
  • Benziq LS
  • Benziq Wash
  • Benzoyl Peroxide Cleanser [DSC]
  • Benzoyl Peroxide Cleanser [OTC]
  • Benzoyl Peroxide Wash [OTC]
  • BP Cleanser [OTC] [DSC]
  • BP Cleansing [OTC]
  • BP Foam
  • BP Foaming Wash
  • BP Gel [OTC]
  • BP Wash
  • BP Wash [OTC]
  • BPO Creamy Wash [OTC]
  • BPO Foaming Cloths
  • BPO [DSC]
  • BPO-10 Wash [OTC]
  • BPO-5 Wash [OTC]
  • Clearplex V [OTC]
  • Clearplex X
  • Clearskin [OTC]
  • Desquam-X Wash [OTC]
  • Inova
  • Lavoclen-4 Acne Wash
  • Lavoclen-4 Creamy Wash [DSC]
  • Lavoclen-8 Acne Wash
  • Lavoclen-8 Creamy Wash [DSC]
  • Neutrogena Clear Pore [OTC]
  • OC8 [OTC]
  • Oscion Cleanser
  • PanOxyl Wash [OTC]
  • PanOxyl [OTC]
  • PanOxyl-4 Creamy Wash [OTC]
  • PanOxyl-8 Creamy Wash [OTC] [DSC]
  • PR Benzoyl Peroxide Wash
  • Riax
  • SE BPO Foaming Cloths [DSC]
  • SE BPO Wash [DSC]
  • TL BPO MX Cleanser [DSC]
  • Zaclir Cleansing

Pharmacologic Category

  • Acne Products
  • Topical Skin Product
  • Topical Skin Product, Acne

Pharmacology

Releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids

Absorption

~5% via skin; gel more penetrating than cream

Metabolism

Converted to benzoic acid in skin

Use: Labeled Indications

Acne vulgaris, acne rosacea: Treatment of mild to moderate acne vulgaris and acne rosacea

Contraindications

Hypersensitivity to benzoyl peroxide or any other component of the formulation.

Dosing: Adult

Acne:

Topical formulations: Apply sparingly once daily; gradually increase to 2 to 3 times/day if needed. If excessive dryness or peeling occurs, reduce dose frequency or concentration. If excessive stinging or burning occurs, remove with mild soap and water; resume use the next day.

Topical cleansers: Wash once or twice daily; control amount of drying or peeling by modifying dose frequency or concentration.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Administration

Note: Avoid contact with eyes and other mucous membranes. Some products may stain certain fabrics; avoid contact with clothing or furniture.

Cleansers: Wet skin areas to be treated prior to administration. Rinse thoroughly and pat dry.

Cloths: Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10 to 20 seconds. Rinse thoroughly and pat dry. Throw away cloth; do not flush.

Foam: Prime can prior to initial use (refer to manufacturer's labeling for priming instructions. Dispense foam into palm of hand or applicator pad and cover entire affected area and rub in until completely absorbed. Some products can remain on skin and others should be rinsed off after a brief period of time (refer to manufacturers labeling). Rinse applicator with water and allow to dry after use; wash hands with soap and water after use.

Other dose forms: After cleansing skin, smooth small amount over affected area. If bothersome dryness or peeling occurs, reduce dose frequency or drug concentration. If excessive stinging or burning occurs after any single application, remove with mild soap and water; resume use the next day.

Storage

Store at 15°C to 30°C (59°F to 86°F).

Drug Interactions

Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Monitor therapy

Adverse Reactions

Frequency not defined.

1% to 10%: Dermatologic: Contact dermatitis, desquamation, erythema, skin irritation, stinging of the skin, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Bleaching effects: May bleach hair, colored fabric, or carpet.

• Hypersensitivity reaction: Rare but serious and potentially life-threatening allergic reactions or severe irritation have been reported with use of topical OTC benzoyl peroxide or salicylic acid containing products; it has not been determined if the reactions are due to the active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. Hypersensitivity reactions may occur within minutes to a day or longer after product use and differ from local skin irritation (redness, burning, dryness, itching, peeling or slight swelling) that may occur at the site of product application. Treatment should be discontinued if hives or itching develop; patients should seek emergency medical attention if reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue develop. Before using a topical OTC acne product for the first time, consumers should apply a small amount to 1 or 2 small affected areas for 3 days to make sure hypersensitivity symptoms do not develop. (FDA Drug Safety Communication 2014).

• Skin irritation: Skin irritation (eg, burning, itching, peeling, redness, swelling) may occur; discontinue use if severe irritation develops.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Concurrent drug therapy issues:

• Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration (Dubina 2009).

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eye, eyelids, lips, mouth, and mucous membranes. Inform patients to use skin protection (eg, sunscreen) and minimize prolonged exposure to sun or tanning beds.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted; ~2% of the applied dose is expected to be absorbed systemically (Akhavan, 2003).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin, itching, peeling, or sensation of warmth. Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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