(BEN zoe il peer OKS ide)
Treatment of mild-to-moderate acne vulgaris and acne rosacea
Hypersensitivity to benzoyl peroxide or any other component of the formulation.
Acne:
Topical formulations: Apply sparingly once daily; gradually increase to 2-3 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.
Refer to adult dosing.
Children ≥12 years and Adolescents: Refer to adult dosing.
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); 8% (42.5 g) [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 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) [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]
Delos: 3.5% (45 g [DSC]) [contains cetyl alcohol, edetate disodium, methylparaben, propylparaben]
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]
Pad, External:
Generic: 3% (30 ea [DSC]); 6% (30 ea [DSC])
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
Frequency not defined.
1% to 10%: Dermatologic: Contact dermatitis, desquamation, erythema, skin irritation, stinging of the skin, xeroderma
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: Discontinue use if severe skin irritation or redness occurs.
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, and mucous membranes. Inform patients to use skin protection and minimize prolonged exposure to sun or tanning beds.
C
Animal reproduction studies have not been conducted; ~2% of the applied dose is expected to be absorbed systemically (Akhavan, 2003).
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
~5% via skin; gel more penetrating than cream
Converted to benzoic acid in skin
- 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 healthcare 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.