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Special Alerts
Confusion Between Durezol® (difluprednate ophthalmic emulsion) and the Topical Wart Remover Durasal™ (salicylic acid, 26%)
December 2011
The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of the potential confusion between the FDA-approved ophthalmic corticosteroid emulsion Durezol® (difluprednate) and the unapproved topical wart remover Durasal™ (salicylic acid, 26%). Serious injury has resulted from the inadvertent administration of salicylic acid in the eye and several cases of near-miss events have been reported due to product name similarity. Healthcare providers should be diligent in specifying the product necessary and pharmacists should be vigilant when filling prescriptions for ophthalmic Durezol® to avoid potential confusion.
For additional information, please refer to http://www.fda.gov/Drugs/DrugSafety/ucm285235.htm.
Pronunciation
(sal i SIL ik AS id)
Generic Available (U.S.)
Yes: Foam, Bar, Cream, gel, lotion, shampoo, soap
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Topically for its keratolytic effect in controlling seborrheic dermatitis or psoriasis of body and scalp, dandruff, and other scaling dermatoses; also used to remove warts, corns, and calluses; acne
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in animal reproduction studies when administered orally. Salicylates cross the placenta (Ostensen, 1998). Systemic absorption of topically applied salicylic acid varies depending on duration and vehicle (9% to 25%) (Akhavan, 2003).
Breast-Feeding Considerations
Oral salicylates are found in breast milk (Bar-Oz, 2003). Systemic absorption of topically applied salicylic acid varies depending on duration and vehicle (9% to 25%) (Akhavan, 2003) Breast-feeding is not recommended by the manufacturer.
Contraindications
Hypersensitivity to salicylic acid or any component of the formulation
Additional contraindications: Virasal®: Impaired circulation (eg, diabetes, peripheral vascular disease); moles, birthmarks; warts with hair growth or on face
Warnings/Precautions
Disease-related concerns:
• Diabetes: Prior to OTC use, consult with healthcare provider if you have diabetes.
• Poor circulation: Prior to OTC use, consult with healthcare provider if have poor circulation.
Other warnings/precautions:
• Appropriate use: For external use only; not for application to areas that are irritated, infected, reddened, birthmarks, genital or facial warts, eyes or mucous membranes.
Adverse Reactions
Frequency not defined.
Central nervous system: Dizziness, headache, mental confusion
Local: Burning and irritation at site of exposure on normal tissue, peeling, scaling
Otic: Tinnitus
Respiratory: Hyperventilation
Metabolism/Transport Effects
None known.
Drug Interactions
There are no known significant interactions.
Mechanism of Action
Produces desquamation of hyperkeratotic epithelium via dissolution of the intercellular cement which causes the cornified tissue to swell, soften, macerate, and desquamate. Salicylic acid is keratolytic at concentrations of 3% to 6%; it becomes destructive to tissue at concentrations >6%. Concentrations of 6% to 60% are used to remove corns and warts and in the treatment of psoriasis and other hyperkeratotic disorders.
Pharmacodynamics/Kinetics
Absorption: Percutaneous; systemic toxicity unlikely with normal use
Time to peak, serum: Within 5 hours of application with occlusion
Dosage
Topical: Children and Adults (consult specific product labeling for use in children <12 years):
Acne:
Cream, cloth, foam, or liquid cleansers (2%): Use to cleanse skin once or twice daily. Massage gently into skin, work into lather and rinse thoroughly. Cloths should be wet with water prior to using and disposed of (not flushed) after use.
Gel (0.5% or 2%): Apply small amount to face in the morning or evening; if peeling occurs, may be used every other day. Some products may be labeled for OTC use up to 3 or 4 times/day. Apply to clean, dry skin
Pads (0.5% or 2%): Use pad to cover affected area with thin layer of salicylic acid 1-3 times/day. Apply to clean, dry skin. Do not leave pad on skin.
Patch (2%): At bedtime, after washing face, allow skin to dry at least 5 minutes. Apply patch directly over pimple being treated. Remove in the morning.
Shower/bath gels or soap (2%): Use once daily in shower or bath to massage over skin prone to acne. Rinse well.
Callus, corns, or warts: Note: For warts: Before applying product, soak area in warm water for 5 minutes; remove loosened wart tissue with a brush, wash cloth, or emery board; dry area thoroughly, then apply medication.
Foam: Apply to affected area twice daily; rub into skin until completely absorbed
Gel or liquid (17%): Apply to each wart and allow to dry. May repeat once or twice daily, up to 12 weeks. Apply to clean dry area.
Gel (6%): Apply to affected area once daily, generally used at night and rinsed off in the morning.
Liquid (27.5%): Apply to each wart; allow to dry then apply a second application. May repeat two-application process once or twice daily, up to 6 weeks
Transdermal patch (15%): Apply directly over affected area at bedtime, leave in place overnight and remove in the morning. Patch should be trimmed to cover affected area. May repeat daily for up to 12 weeks.
Transdermal patch (40%): Apply directly over affected area, leave in place for 48 hours. Some products may be cut to fit area or secured with adhesive strips. May repeat procedure for up to 12 weeks. Apply to clean, dry skin
Dandruff, psoriasis, or seborrheic dermatitis:
Cream (2.5%): Apply to affected area 3-4 times daily. Apply to clean, dry skin. Some products may be left in place overnight.
Foam: Apply to affected area twice daily; rub into skin until completely absorbed
Ointment (3%): Apply to scales or plaques on skin up to 4 times per day (not for scalp or face)
Shampoo (1.8% to 3%): Massage into wet hair or affected area; leave in place for several minutes; rinse thoroughly. Labeled for OTC use 2-3 times a week, or as directed by healthcare provider. Some products may be left in place overnight.
Geriatric Considerations
No specific considerations are needed if used according to recommended doses and duration of use. Many elderly may have diabetes or impaired circulation and avoidance of topical salicylic acid would be advised.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause confusion
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol, foam, topical: 6% (70 g)
Salvax: 6% (70 g, 200 g) [ethanol free]
Bar, topical [soap]: 2% (113 g)
OXY®: 0.5% (119 g)
Cloth, topical:
Neutrogena® Oil-Free Acne Wash: 2% (30s)
Cream, topical: 6% (400 g, 480 g)
Clean & Clear® Advantage® Acne Cleanser: 2% (148 mL)
Clean & Clear® Advantage® Acne Spot Treatment: 2% (22 g) [contains benzalkonium chloride, ethanol 14%]
Clean & Clear® Blackhead Clearing Scrub: 2% (141 g, 226 g) [contains ethanol]
Clean & Clear® Dual Action Moisturizer: 0.5% (120 mL) [contains ethanol]
LupiCare® Psoriasis: 2% (227 g)
Neutrogena® Acne Stress Control: 2% (125 g) [with microbeads]
Neutrogena® Oil-Free Acne: 2% (125 mL) [contains ethanol, tartrazine; with microbeads]
Neutrogena® Oil-Free Acne Wash Cream Cleanser: 2% (200 mL) [contains ethanol]
Neutrogena® Oil-Free Anti-Acne: 0.5% (50 g) [contains aloe]
Salex®: 6% (454 g)
Salitop™: 6% (400 g) [contains ethanol]
Cream, topical [wash]:
Neutrogena® Oil-Free Acne Stress Control: 2% (172 g)
Gel, topical: 6% (40 g)
Clean & Clear® Advantage® Invisible Acne Patch: 2% (1.9 mL) [contains ethanol]
Clean & Clear® Invisible Blemish Treatment: 2% (22 mL) [contains ethanol 28%]
Compound W®: 17.6% (7 g) [contains ethanol 67.5%]
Dermarest® Psoriasis Medicated Scalp Treatment: 3% (118 mL)
Dermarest® Psoriasis Medicated Skin Treatment: 3% (118 mL)
Dermarest® Psoriasis Overnight Treatment: 3% (56.7 g)
Hydrisalic®: 6% (28 g) [contains ethanol]
Keralyt®: 3% (30 g); 6% (40 g, 100 g) [contains ethanol 21%]
Neutrogena® Oil-Free Acne Wash: 2% (177 mL, 296 mL) [contains tartrazine]
Neutrogena® Rapid Clear® Acne Eliminating: 2% (15 mL) [contains ethanol 38%]
OXY®: 2% (355 mL) [contains aloe]
OXY® Body Wash: 2% (355 mL)
OXY® Body Wash: 2% (355 mL) [contains aloe]
OXY® Chill Factor®: 2% (142 g)
OXY® Face Wash: 2% (177 mL) [contains aloe]
OXY® Maximum: 2% (142 g)
OXY® Spot Treatment: 1% (14.7 g) [contains aloe]
Sal-Plant®: 17% (14 g) [contains isopropyl alcohol]
Zapzyt® Acne Wash: 2% (188.5 g) [ethanol free]
Zapzyt® Pore Treatment: 2% (22 mL) [ethanol free]
Gel, topical [peel]:
Neutrogena® Advanced Solutions™: 2% (40 g)
Liquid, topical:
Clean & Clear® Advantage® Oil-Free Acne: 0.5% (120 mL) [contains benzalkonium chloride]
Clean & Clear® Deep Cleaning: 2% (240 mL) [contains benzoic acid, ethanol]
Compound W®: 17.6% (9 mL) [contains ethanol 21.2%]
Dr. Scholl's® Clear Away® Wart Remover Fast-Acting: 17% (9.8 mL) [contains ethanol 18% w/w; includes 20 cover-up discs]
Dr. Scholl's® Corn/Callus Remover: 12.6% (9.8 mL)
Dr. Scholl's® Corn/Callus Remover: 12.6% (9.8 mL) [contains ethanol 18% w/w]
DuoFilm®: 17% (9.8 mL) [contains ethanol]
Freezone®: 17.6% (9.3 mL) [contains ethanol]
Fung-O®: 17% (15 mL) [contains ethanol 2%]
Gets-It®: 13.9% (15 mL)
Gordofilm: 16.7% (15 mL)
Mosco® Callus & Corn Remover: 17.6% (9 mL) [contains ethanol 27%]
Neutrogena® Blackhead Eliminating™ Daily Scrub: 2% (125 mL)
Neutrogena® Clear Pore™ Oil-Controlling Astringent: 2% (236 mL) [contains ethanol 45%]
Neutrogena® Oil-Free Acne Stress Control: 2% (50 mL)
Palmer's® Skin Success Acne Cleanser: 0.5% (240 mL) [contains aloe, vitamin E]
Salactic®: 17% (15 mL) [contains isopropyl alcohol]
Scalpicin® Anti-Itch: 3% (44 mL, 74 mL) [contains aloe]
Tinamed® Corn and Callus Remover: 17% (15 mL)
Tinamed® Wart Remover: 17% (15 mL)
Virasal®: 27.5% (10 mL) [contains isopropyl alcohol]
Wart-Off® Maximum Strength: 17.5% (14.8 mL) [contains ethanol]
Liquid, topical [body scrub with microbeads]:
Neutrogena® Body Clear®: 2% (250 mL) [contains tartrazine]
Liquid, topical [body wash]:
Neutrogena® Body Clear®: 2% (250 mL) [contains tartrazine]
Liquid, topical [foam]:
Neutrogena® Oil-Free Acne Wash Foam Cleanser: 2% (150 mL)
Liquid, topical [foam/wash]:
Neutrogena® Oil-Free Acne Stress Control: 0.5% (177 mL)
Liquid, topical [mask/wash]:
Neutrogena® Oil-Free Acne Wash 60 Second Mask Scrub: 1% (170 g) [ethanol free]
Lotion, topical: 6% (414 mL); 6% (400 g)
Dermarest® Psoriasis Medicated Moisturizer: 2% (118 mL)
Neutrogena® Rapid Clear® Acne Defense: 2% (50 mL) [contains ethanol]
OXY® Post-Shave: 0.5% (50 g) [contains aloe]
Salex®: 6% (237 mL)
Salitop™: 6% (414 mL) [contains ethanol]
Ointment, topical:
MG217® Sal-Acid: 3% (57 g) [contains vitamin E]
Pad, topical:
Clean & Clear® Blackhead Clearing Daily Cleansing: 1% (70s) [contains ethanol 39%]
Curad® Mediplast®: 40% (25s)
Neutrogena® Blackhead Eliminating™: 0.5% (28s)
Neutrogena® Blackhead Eliminating™ 2-in-1 Foaming Pads: 0.5% (28s)
Neutrogena® Rapid Clear®: 2% (60s) [contains benzalkonium chloride, ethanol 35%]
OXY® Chill Factor®: 2% (90s) [contains ethanol 46% v/v]
OXY® Daily: 0.2% (90s) [contains ethanol 46% v/v]
OXY® Daily Cleansing: 0.5% (90s) [contains ethanol 34% v/v]
OXY® Maximum Daily Cleansing: 2% (55s, 90s) [contains ethanol 46% v/v]
Stridex® Essential Care®: 1% (55s) [ethanol free; contains vitamin A, vitamin E]
Stridex® Facewipes To Go®: 0.5% (32s) [contains aloe, ethanol 28%]
Stridex® Maximum Strength: 2% (55s, 90s) [ethanol free]
Stridex® Sensitive Skin: 0.5% (55s, 90s) [ethanol free]
Patch, topical:
Compound W® One Step Invisible Strip: 14% (14s)
Compound W® One Step Wart Remover for Feet: 40% (20s)
Compound W® One-Step Wart Remover: 40% (14s)
Compound W® One-Step Wart Remover for Kids: 40% (12s)
Dr. Scholl's® Callus Removers: 40% (4s)
Dr. Scholl's® Callus Removers: 40% (4s) [includes 6 cushions]
Dr. Scholl's® Clear Away® One Step Wart Remover: 40% (14s)
Dr. Scholl's® Clear Away® Plantar Wart Remover For Feet: 40% (24s)
Dr. Scholl's® Clear Away® Wart Remover: 40% (18s)
Dr. Scholl's® Clear Away® Wart Remover Invisible Strips: 40% (18s)
Dr. Scholl's® Corn Removers: 40% (9s)
Dr. Scholl's® Corn Removers: 40% (9s) [includes 9 cushions]
Dr. Scholl's® Extra Thick Corn Removers: 40% (9s)
Dr. Scholl's® Extra-Thick Callus Removers: 40% (4s)
Dr. Scholl's® Extra-Thick Callus Removers: 40% (4s) [includes 4 cushions]
Dr. Scholl's® For Her Corn Removers: 40% (6s) [includes 6 cushions]
Dr. Scholl's® OneStep Callus Removers: 40% (4s)
Dr. Scholl's® OneStep Corn Removers: 40% (6s)
Dr. Scholl's® Small Corn Removers: 40% (9s)
Dr. Scholl's® Ultra-Thin Corn Removers: 40% (9s) [includes 9 covers]
Mosco® One Step Corn Remover: 40% (8s)
Trans-Ver-Sal®: 15% (10s, 25s) [20 mm PlantarPatch]
Trans-Ver-Sal®: 15% (15s, 40s) [contains propylene glycol]
Trans-Ver-Sal®: 15% (12s, 40s) [contains propylene glycol; 12 mm AdultPatch]
Shampoo, topical: 6% (177 mL)
Aliclen™: 6% (177 mL)
Beta Sal®: 3% (480 mL)
Denorex® Extra Strength Protection: 3% (118 mL, 355 mL)
DHS™ Sal: 3% (120 mL)
Ionil Plus®: 2% (240 mL) [conditioning shampoo]
Ionil®: 2% (120 mL)
LupiCare® Dandruff: 2% (237 mL)
LupiCare® Psoriasis: 2% (237 mL)
Neutrogena® Maximum Strength T/Sal®: 3% (135 mL)
P&S®: 2% (118 mL, 236 mL)
Salex®: 6% (177 mL)
Selsun blue® Deep Cleaning Micro-Bead Scrub: 3% (325 mL) [contains aloe, benzyl alcohol, moisturizers]
Selsun blue® Naturals Island Breeze: 3% (325 mL) [contains aloe, benzyl alcohol]
Selsun blue® Naturals Itchy Dry Scalp: 3% (207 mL, 325 mL) [contains aloe, benzyl alcohol, moisturizers]
Thera-Sal: 3% (180 mL)
Shampoo/Conditioner, topical:
Denorex® Extra Strength Protection 2-in-1: 3% (118 mL, 355 mL)
Dermarest® Psoriasis Medicated Shampoo/Conditioner: 3% (236 mL)
Pricing: U.S. (www.drugstore.com)
Gel (Keralyt)
6% (40): $55.99
Kit (Salex)
6% (cream) (1): $348.79
6% (lotion) (597): $204.48
Liquid (Virasal)
27.5% (10): $109.99
Lotion (Salicylic Acid)
6% (414): $79.99
Shampoo (Salex)
6% (177): $173.42
References
Akhavan A and Bershad S, "Topical Acne Drugs: Review of Clinical Properties, Systemic Exposure, and Safety," Am J Clin Dermatol, 2003, 4(7):473-92.
Bar-Oz B, Bulkowstein M, Benyamini L, et al, "Use of Antibiotic and Analgesic Drugs During Lactation," Drug Saf, 2003, 26(13):925-35.
Ostensen M, "Nonsteroidal Anti-inflammatory Drugs During Pregnancy," Scand J Rheumatol Suppl, 1998, 107:128-32.
International Brand Names
Lexi-Comp.com
Last full review/revision January 2012
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