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Salicylic Acid

Class: Keratolytic Agents
ATC Class: D01AE12
VA Class: DE500
CAS Number: 69-72-7
Brands: Aveeno Clear Complexion, Clearasil, Compound W, Denorex, Dermarest, DHS Sal, Dr Scholl’s, DuoFilm, Freezone, Hydrisalic, Ionil Plus, Keralyt, Kerasal, Mediplast, Meted, MG 217 Sal-Acid, Neutrogena Rapid Clear, Neutrogena T-Sal, Noxzema, Occlusal, Oxy, P&S, Psoriasin, Sal-Acid, Salactic, Salex, Sal-Plant, Sebasorb, Stridex, Tarsum, Trans-Ver-Sal, Versiclear, Wart-off

Warning(s)

Special Alerts:

[Posted 06/25/2014] ISSUE: FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.

These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.

The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands. They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

BACKGROUND: Based on the information reported to FDA, it cannot be determined if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. FDA is continuing to monitor and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.

RECOMMENDATION: Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label. For more information visit the FDA website at: and .

Introduction

Keratolytic agent; derivative of benzoic acid.a o

Uses for Salicylic Acid

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Acne

Salicylic acid is used alone or in combination with other drugs (e.g., resorcinol, sulfur) for the symptomatic treatment of acne.a c k

Seborrheic Dermatitis and Psoriasis

Salicylic acid is used for self-medication to control seborrheic dermatitis of the body and scalp, psoriasis of the body and scalp, dandruff, and other scaling dermatoses.a f l m o q r s

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Cream, lotion, and gel (6% salicylic acid) used to aid in the exfoliation of dry, scaly skin associated with psoriasis.l o p

Hyperkeratosis

Salicylic acid is used topically as self-medication for its keratolytic and caustic effect in the removal of common and plantar warts;a d h j l also used to remove corns and calluses.a e i n o p

Salicylic acid is used for treatment of localized hyperkeratosis that occurs on the palms and soles.a l o

Tinea Versicolor

Salicylic acid is used in combination with an antifungal (sodium thiosulfate) for the treatment of tinea versicolor (Malassezia furfur) infection.g

Salicylic Acid Dosage and Administration

General

  • Consult a clinician prior to initiating self-medication for a condition that covers a large area of the body.f m q r

Administration

Topical Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Apply topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, or solution.h i j k l m n o q r s t

For external use only;c d e f h i j k not for ophthalmic, oral, or intravaginal use.l o p If contact with the eye(s) occurs, wash thoroughly with water.d e f h k m n q r

Rinse hands thoroughly after topical application, unless hands are being treated.l o p

Do not use systemically because of severe irritating effect on GI mucosa and other tissues.a b

Apply salicylic acid 6% cream (Salex), lotion (Salex), or gel (Keralyt, Hydrisalic) topically to affected area(s) at bedtime.l o p Hydrate affected area of skin (e.g., with wet packs or baths) for ≥5 minutes prior to application and cover with occlusive dressing.l o p In the morning, wash affected area of skin; may apply a bland emollient if affected skin is irritated or excessively dry.l o If occlusion is not possible, may apply more frequently.l o p However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism.l (See Salicylate Toxicity under Cautions.)

Acne (Self-medication)

Apply topically using appropriate preparations containing salicylic acid 0.5–2%.c

Cleanse and dry the affected area prior to topical application.c

Apply a thin layer of appropriate salicylic acid preparation (e.g., cream, gel, lotion) to affected areas.c

Apply cake or cleansing solution with water, in place of regular soap; rinse thoroughly with warm water and pat dry.c k

Seborrheic Dermatitis and Psoriasis (Self-medication)

Apply topically using appropriate preparations containing salicylic acid 1.8–3%.f

Apply cream, lotion, ointment, gel, or solution to affected areas of skin.f

Apply preparations formulated as soaps or shampoo to affected area(s) in place of regular soap or shampoo.f m

Hyperkeratosis

Corn and Callus Removal (Self-medication): Apply topically using appropriate preparations containing salicylic acid 12–40% (e.g., plaster, solution in flexible collodion) or 3% (gel).e

Do not apply on irritated or infected skin.e n

Cleanse and dry the affected area prior to topical application.e i n

Trim plaster to fit completely over the callus or corn and apply.e i

Apply a small amount of solution in flexible collodion with an applicator to sufficiently cover corn or callus and allow to dry.e n

Apply a small amount of solution or gel (e.g., 1 drop at a time) with an applicator to sufficiently cover corn or callus; allow to dry.e h

May soak affected area(s) in warm water for 5 minutes to aid in corn or callus removal.e i n

Wart Removal (Self-medication): Apply topically using appropriate preparations containing salicylic acid 12–40% (plaster) or 5–17% (solution in flexible collodion).d h j

Do not use on moles, birthmarks, warts with hair(s) growing from them, genital warts, or warts on the face or mucous membranes.d h j

Do not apply on irritated, reddened, or infected skin.d

Cleanse and dry the affected area prior to topical application; may soak affected area(s) in warm water for 5 minutes.d

Trim plaster to fit completely over the wart and apply.d j

Prior to application of plaster in a karaya gum and polyethylene glycol vehicle (Trans-Ver-Sal), gently smooth wart with emery board, and carefully apply a drop of warm water to wart, using a cotton-tipped applicator. Trim plaster to completely fit over wart; if necessary, secure plaster in place with medical tape.j Ensure that the plaster does not touch unaffected surrounding skin.j

Apply a small amount of solution or gel (e.g., one drop at a time) with an applicator to sufficiently cover wart(s); allow to dry.d h

Dosage

Pediatric Patients

Acne
Topical

Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily.c Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary.c If dryness or peeling occurs, reduce application to once daily or every other day.c

Seborrheic Dermatitis and Psoriasis
Scalp
Topical

Self-medication for children >2 years of age: Apply 3% salicylic acid solution to affected area(s) of the scalp 1–4 times daily or as directed by a clinician.f s

Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp.m Leave lather on scalp for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m

Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing.u Allow to remain on scalp for 5 minutes; add water and lather, and then rinse thoroughly.u Gradually increase treatment times to 1 hour, or as directed by a clinician.u Alternatively, apply to wet hair and lather; allow to remain on scalp for up to 10 minutes, then rinse.u Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.u

Body (Excluding Scalp)
Topical

Self-medication for children >2 years of age: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, ointment, lotion, gel) to affected area(s) 1–4 times daily or as directed by a clinician.f q r

Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap.m Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m

Children ≥2 years old: Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p When improvement occurs, apply occasionally to maintain remission.l o p In areas where occlusion is difficult or impossible, apply more frequently.l o p

Hyperkeratosis
Corn and/or Callus Removal
Topical

Children ≥2 years of age: Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p In areas where occlusion is difficult or impossible, apply more frequently.o

Self-medication for children >12 years of age: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician.t

Wart Removal
Topical

Children ≥2 years of age: Apply 15% salicylic acid plaster in a karaya gum and polyethylene glycol vehicle once daily at bedtime; leave in place for ≥8 hours, then remove and discard.d j Repeat every 24 hours as needed until wart is completely removed or for up to 12 weeks.d j

Tinea Versicolor
Topical

Children >12 years of age: Apply combination lotion (salicylic acid 1% and sodium thiosulfate 25%) in a thin film to all affected area(s) twice daily or as directed by a clinician.v

Adults

Acne
Topical

Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily.c Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary.c If dryness or peeling occurs, reduce application to once daily or every other day.c

Seborrheic Dermatitis and Psoriasis
Scalp
Topical

Self-medication: Apply 3% salicylic acid solution to affected area(s) of the scalp 1–4 times daily or as directed by a clinician.f s

Self-medication: Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp.f m Leave lather on for several minutes, then rinse thoroughly; repeat if necessary.f m Use at least twice weekly or as directed by a clinician.f m

Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing.u Allow to remain on scalp for 5 minutes and then rinse thoroughly.u Gradually increase treatment times to 1 hour, or as directed by a clinician.u Alternatively, apply to wet hair; allow to remain on scalp for up to 10 minutes, then rinse.u Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.u

Body (Excluding Scalp)
Topical

Self-medication: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, ointment, lotion, gel) to affected area(s) 1–4 times daily or as directed by a clinician.f q r

Self-medication: Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap.m Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary.m Use at least twice weekly or as directed by a clinician.f m

Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude.l o p When improvement occurs, apply occasionally to maintain remission.l o p In areas where occlusion is difficult or impossible, apply more frequently.l o p

Hyperkeratosis
Corn and/or Callus Removal
Topical

Self-medication: Apply 12–40% salicylic acid plaster to corn or callus and cover with cushion provided by manufacturer.e i After 48 hours, remove cushion and plaster.e i May cover with cushion provided by manufacturer.i Repeat every 48 hours as needed until corn or callus is removed, for up to 14 days.e i

Self-medication: Apply 12–17.6% salicylic acid solution or gel in flexible collodion (e.g., 1 drop at a time) to sufficiently cover corn or callus.e n Repeat once or twice daily as needed for up to 14 days.e n

Self-medication: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician. t

Apply 6% salicylic acid gel, cream, or lotion to the affected area(s) at bedtime and occlude.l o p In areas where occlusion is difficult or impossible, apply more frequently.p o

Wart Removal
Topical

Self-medication: Apply 12–40% salicylic acid plaster to wart.d After 48 hours, remove and repeat as needed until wart is completely removed or for up to 12 weeks.d

Self-medication: Apply 5–17% salicylic acid solution or gel in flexible collodion (e.g., 1 drop at a time) to sufficiently cover wart(s).d h Repeat once or twice daily for up to 12 weeks.d h

Apply 15% salicylic acid plaster in a karaya gum and polyethylene glycol vehicle to wart(s) once daily at bedtime; leave in place for ≥8 hours, then remove and discard.d j Repeat every 24 hours as needed until wart is completely removed for up to 12 weeks.d j

Tinea Versicolor
Topical

Self-medication: Apply combination lotion (salicylic acid 1% and sodium thiosulfate 25%) in a thin film to affected areas twice daily or as directed by a clinician.g

Prescribing Limits

Pediatric Patients

Acne
Topical

Self-medication: Apply a maximum 3 times daily.c

Seborrheic Dermatitis and Psoriasis
Scalp
Topical

Self-medication for children >2 years of age: Apply 3% salicylic acid solution a maximum 4 times daily or as directed by a clinician.f s

Body (Excluding Scalp)
Topical

Self-medication for children >2 years of age: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, lotion, ointment, gel) a maximum 4 times daily or as directed by a clinician.f

Adults

Acne
Topical

Self-medication: Apply a maximum 3 times daily.c

Seborrheic Dermatitis and Psoriasis
Scalp
Topical

Self-medication: Apply 3% salicylic acid solution for a maximum 4 times daily or as directed by a clinician.f s

Body (Excluding Scalp)
Topical

Self-medication: Apply appropriate 1.8–3% salicylic acid preparation (e.g., cream, lotion, ointment, gel) a maximum 4 times daily or as directed by a clinician.f

Hyperkeratosis
Corn and/or Callus Removal
Topical

Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 14 days.e i n

Wart Removal
Topical

Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 12 weeks.d h j

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.l o

Renal Impairment

No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.l o

Cautions for Salicylic Acid

Contraindications

  • Known sensitivity to salicylic acid or any other ingredient in the formulation.l o

  • 6% salicylic acid cream, lotion, and gel: Children <2 years of age.l o

Warnings/Precautions

Warnings

Salicylate Toxicity

Risk of salicylate toxicity (e.g., nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, psychic disturbances) after prolonged or excessive topical use over large areas.l o p If salicylic acid toxicity occurs, immediately discontinue; administer fluids to promote urinary excretion, and administer sodium bicarbonate (oral or IV) if clinically necessary.l o

Avoid other salicylates (e.g., aspirin, salicylate athletic creams) to minimize exposure to salicylic acid.l o (See Interactions under Cautions.)

Use of Fixed Combinations

When used in fixed combination with urea, coal tar, and sodium thiosulfate, consider the cautions, precautions, and contraindications associated with these agents.g u

General Precautions

Topical Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Possible excessive erythema or scaling if applied to open skin lesions.l o p

If excessive burning, irritation, stinging, or peeling occurs, discontinue use and consult a clinician.g o

Possible necrosis of normal skin with overuse.a

Concomitant Illnesses

Do not use salicylic acid wart, corn, and callus removal preparations in patients with diabetes or with poor blood circulation.d h n

Specific Populations

Pregnancy

Category C.l o

Lactation

Discontinue nursing or the drug.l o If used by nursing women, avoid applying to the chest area.l

Pediatric Use

Salicylic acid 6% cream, lotion, and gel and 15% plaster not recommended in children <2 years of age.l j o (See Contraindications.)

Increased risk of salicylate toxicity with prolonged, excessive use in children <12 years of age.l o Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)

Use of salicylates in children with varicella infection or influenza-like illnesses reportedly is associated with an increased risk of developing Reye’s syndrome.b l o US Surgeon General, AAP Committee on Infectious Diseases, FDA, and other authorities advise that salicylates not be used in children and teenagers with varicella or influenza, unless directed by a clinician.b l o

Hepatic Impairment

Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial hepatic impairment.l o p Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)

Renal Impairment

Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial renal impairment.l o p Limit treatment area and monitor for possible signs of salicylate toxicity.l o (See Salicylate Toxicity under Cautions.)

Common Adverse Effects

Erythema,l o p scaling,l o p burning,g o stinging,g o peeling.c

Interactions for Salicylic Acid

Topical Acne Preparations

Cumulative irritant or drying effect.c k If excessive dryness occurs, use only one topical medication unless directed by a clinician.c

Topical Salicylate Preparations

Increased risk of salicylate toxicity.l o

Protein-bound Drugs

Potential for salicylate to displace or to be displaced by other protein-bound drugs.b l o

Specific Drugs

Drug

Interaction

Comments

Acidifying agents

Drugs that decrease urine pH may decrease salicylate excretionl

Anticoagulants (warfarin, heparin)

Increased risk of bleedingb l o

May displace warfarin from protein-binding sites, leading to prolongation of PT and bleeding timeb l o

Antidiabetic agents (sulfonylureas)

Potential for increased hypoglycemic effectb l o

Aspirin

Increased risk of salicylate toxicityl

Avoid concomitant usel

Corticosteroids

Decreased plasma salicylate concentrationsb

Potential increased plasma salicylate concentrations and salicylate toxicity when corticosteroids are discontinuedb l o

Diuretics

Increased plasma salicylate concentrationsl o

Methotrexate

Possible increased methotrexate toxicity because of displacement from protein binding sitesb l o

Pyrazinamide

Possible prevention or reduction of hyperuricemia associated with pyrazinamideb l o

Sulfur

Possible synergistic keratolytic effecta

Uricosuric agents (probenecid, sulfinpyrazone)

Reduced uricosuric effect of uricosuric agentsb l o

Salicylic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed percutaneously following topical application.b l

Following topical application of salicylic acid 6% gel, >60% absorbed, with peak plasma concentration usually attained within 5 hours (under occlusion).l o

Onset

In vitro, plaster (Trans-Ver-Sal) released about 16, 48, 65, 79, 89, and 100% of the salicylic acid dose by 0.5, 1, 2, 4, 8, and 24 hours, respectively.a

Plasma Concentrations

Following topical application of salicylic acid 6% gel, peak serum salicylate concentrations were <50 mcg/mL; concentrations >300 mcg/mL generally associated with salicylate toxicity.l o

Distribution

Extent

Distributed in extracellular space.l o

Plasma Protein Binding

50–80%.l o

Special Populations

Patients with a contracted extracellular space secondary to dehydration or diuretics may have increased plasma salicylate levels.l o

Elimination

Elimination Route

Excreted principally in urine as salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).l o

Stability

Storage

Topical

Cream, Lotion

20–25°C.l Do not freeze.l

Store combination lotion (salicylic acid 1% and sodium thiosulfate 25%) at 15–30°C.g

Solution

Solution in flexible collodion: Tightly closed containers at 15–30°C.a Flammable; keep away from heat and open flame.a d e

Gel

Tightly closed containers at 15–30°C.a p

Gel in flexible collodion: Tightly closed containers at 15–30°C.a Flammable, keep away from heat and open flame.a d e

Shampoo

Salicylic acid 3%: Tightly closed containers; avoid excessive heat or cold.m

Plaster

Well-closed containers at 15–30°C.a

Actions

  • Exact mechanism(s) of action not elucidated; appears to soften and destroy the stratum corneum by increasing endogenous hydration that causes the cornified epithelium (horny layer) of the skin to swell, soften, and desquamate.a j l o

  • In low concentrations, has keratoplastic activity (correction of abnormal keratinization); at concentrations ≥1%, has keratolytic activity (causes peeling of skin); and at concentrations ≥20%, has a caustic effect.a

  • Has weak antifungal and antibacterial activity.a

  • May promote the penetration of other active ingredients and have a comedolytic effect.a

  • Requires moisture to exert its action on the skin and for maceration and desquamation of epidermal tissue.a

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Importance of keeping salicylic acid preparations out of reach of children.g m o

  • Importance of avoiding heat or flames during use of certain salicylic acid collodion formulations.n o

  • For external use only.o Importance of avoiding contact with eyes.k n q r

  • Importance of rinsing hands thoroughly after topical application, unless hands are being treated.l o p

  • Advise patients that salicylic acid topical preparations used concurrently with other topical medications may increase skin dryness or irritation.c

  • Importance of not using for prolonged periods of time for self-medication of dandruff, seborrheic dermatitis, or psoriasis; importance of consulting a clinician if the condition worsens or does not improve after regular use.f

  • Advise patients that, when salicylic acid preparations are used for wart removal, visible improvement generally occurs during the first several days of treatment and complete removal may require 3–12 weeks of use.j

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.l o p

  • Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.l o

  • Importance of informing patients of other important precautionary information. (See Cautions.) o

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Salicylic Acid

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Topical

Cake

0.5%

Aveeno Clear Complexion Cleansing Bar

Johnson & Johnson

Oxy Bar Soap

Mentholatum

2%

Salicylic Acid Cleansing Bar

Stiefel

Cleansing Cream

2%

Clearasil Oil Control Cream Cleanser

Reckitt Benckiser

Clearasil StayClear Skin Perfecting Wash

Reckitt Benckiser

Cleansing Pledgets (saturated with solution)

0.5%

Oxy Daily Cleansing Pad (with alcohol 34%)

Mentholatum

Stridex Sensitive Skin Pads (with SD alcohol 28% and aloe)

Blistex

1%

Stridex Essential Care Pads

Blistex

2%

Clearasil StayClear Acne Fighting Cleansing Wipes

Reckitt Benckiser

Clearasil StayClear Daily Pore Cleansing Pads

Reckitt Benckiser

Clearasil Ultra Deep Pore Cleansing Pads (with propylene glycol and parabens)

Reckitt Benckiser

Noxzema Triple Clean Pads (with SD-alcohol 40)

Procter & Gamble

Oxy Blackhead Pads (with alcohol 46%)

Mentholatum

Oxy Daily Cleansing Pads (with alcohol 46%)

Mentholatum

Oxy Maximum Cleansing Pads (with alcohol 46%)

Mentholatum

Stridex Pads Maximum Strength (with SD alcohol 40 44%)

Blistex

Cleansing Solution

2%

Noxzema Triple Clean Blackhead Cleanser

Proctor & Gamble

Oxy Body Wash (with parabens and propylene glycol)

Mentholatum

Oxy Face Wash

Mentholatum

Cleansing Suspension

2%

Clearasil StayClear Daily Facial Scrub

Reckitt Benckiser

Oxy Maximum Face Scrub (with parabens and propylene glycol)

Mentholatum

Cream

6%

Salex (with parabens)

Coria

Gel

1%

Clearasil Blackhead Control

Reckitt Benckiser

2%

Neutrogena Rapid Clear Acne Eliminating (with propylene glycol)

Neutrogena

Stridex Clear Gel Maximum Strength (with SD alcohol 9.3%)

Blistex

3%

Dermarest Psoriasis Medicated Scalp Treatment (with SD alcohol 40, propylene glycol, and parabens)

Del

Dermarest Psoriasis Medicated Skin Treatment (with parabens and propylene glycol)

Del

Keralyt (with SD-40 alcohol 21% and propylene glycol)

Summers

6%

Hydrisalic (with SD alcohol 40B and propylene glycol)

Pedinol

Keralyt (with SD-40 alcohol 21% and propylene glycol)

Summers

17%

Sal-Plant Gel (with isopropyl alcohol 2.5% in flexible collodion)

Pedinol

17.6%

Compound W Gel (with alcohol 67.5% in flexible collodion)

Prestige

Lotion

2%

Dermarest Psoriasis Medication Moisturizer (with parabens)

Del

Sebasorb (with attapulgite activated, acetyl alcohol, and propylene glycol)

Summers

6%

Salex (with parabens)

Coria

Ointment

3%

MG 217 Sal-Acid

Triton

Plaster

15%

Trans-Ver-Sal (with karaya and propylene glycol)

Doak

40%

Compound W One Step Invisible Strips

Prestige

Compound W One Step Pads

Prestige

Curad Mediplast

Beiersdorf

Dr Scholl’s Callus Remover

Schering-Plough

Dr Scholl’s Clear Away Medicated Disk

Schering-Plough

Dr Scholl’s Clear Away One-Step Invisible Strips

Schering-Plough

Dr Scholl’s Clear Away Plantar for Feet

Schering-Plough

Sal-Acid

Pedinol

Shampoo

2%

Ionil Plus (with SD alcohol 40 12%)

Healthpoint

P&S (with methylparaben and propylparaben)

Aero

3%

Denorex Extra Strength Shampoo (with propylene glycol)

Prestige

DHS Sal Shampoo

Person & Covey

Neutrogena T/Sal Maximum Strength

Neutrogena

Psoriasin Therapeutic Shampoo & Body Wash

Alva-Amco Pharmacal

Solution

2%

Noxzema 2-in-1 Astringent (with SD-alcohol 40)

Procter & Gamble

Noxzema Continuous Clean Clarifying Toner

Procter & Gamble

3%

Dermarest Psoriasis Medicated Overnight Treatment

Del

16.7%

Gordofilm (in flexible collodion)

Gordon

17%

Dr Scholl’s Clear Away Fast Acting Liquid (with SD alcohol 32 17% and ether 52% in flexible collodion)

Schering-Plough

Dr Scholl’s Liquid Corn/Callus Remover (with alcohol SD 32 18% and ether 53% in flexible collodion)

Schering-Plough

DuoFilm (with alcohol SD 32 17% and ether 52% in flexible collodion)

Schering-Plough

Occlusal-HP (with isopropyl alcohol 63% in polyacrylic vehicle)

Bioglan

Salactic Film (with isopropyl alcohol 2.7% in flexible collodion)

Pedinol

Wart-Off (with alcohol 26.35% in flexible collodion)

Pfizer

17.6%

Compound W Liquid (with alcohol 21.2% and ether 63.6% in flexible collodion)

Prestige

Freezone (with alcohol 33% and ether 65.5% in flexible collodion)

Prestige

Salicylic Acid Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Lotion

1% with Sodium Thiosulfate 25%

Versiclear (with propylene glycol)

Hope

Ointment

5% with Urea 10%

Kerasal Foot Ointment

Alterna

Shampoo

3% with Coal Tar Solution 10% (equivalent to 2% coal tar)

Tarsum

Summers

3% with Colloidal Sulfur 5%

Meted

DUSA

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 07/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Keralyt 6% Gel (SUMMERS LABS): 40/$55.99 or 120/$145.97

RE SA 6% Lotion (KYLEMORE PHARMACEUTICALS): 414/$89.99 or 828/$165.97

Salex 6% (Cream) Kit (VALEANT): 1/$348.79 or 3/$1,031.15

Salex 6% (Lotion) Kit (VALEANT): 597/$204.48 or 1791/$588.52

Salex 6% Shampoo (VALEANT): 177/$152.99 or 531/$445.97

Salicylic Acid 6% Lotion (PERRIGO PHARMACEUTICALS): 414/$79.99 or 1242/$214.98

Salicylic Acid 6% Shampoo (PRUGEN): 177/$50.99 or 531/$125.96

Salkera 6% Foam (ONSET DERMATOLOGICS): 60/$157.29 or 180/$447.67

Virasal 27.5% Liquid (ELORAC): 10/$154.91 or 30/$436.56

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 25, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS Drug Information 2007. McEvoy GK, ed. Salicylic Acid. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3545-6.

b. AHFS Drug Information 2007. McEvoy GK, ed. Salicylates General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2011-23.

c. Department of Health and Human Services, Food and Drug Administration. Part 333---Topical antimicrobial drug products for over-the-counter human use. Subpart D---Topical acne drug products. (21 CFR Ch. 1 (4-1-07 Ed.)) 2007:228-9.

d. Department of Health and Human Services, Food and Drug Administration. Part 358---Miscellaneous external drug products for over-the-counter human use. Subpart B---Wart remover drug products. (21 CFR Ch. 1 (4-1-07 Ed.)) 2007:309-10.

e. Department of Health and Human Services, Food and Drug Administration. Part 358---Miscellaneous external drug products for over-the-counter human use. Subpart F---Corn and callus remover drug products. (21 CFR Ch. 1 (4-1-07 Ed.)) 2007:311-3.

f. Department of Health and Human Services, Food and Drug Administration. Part 358---Miscellaneous external drug products for over-the-counter human use. Subpart H---Drug products for the control of dandruff, seborrheic dermatitis, and psoriasis. (21 CFR Ch. 1 (4-1-07 Ed.)) 2007:315-7.

g. Hope Pharmaceuticals. Versiclear (salicylic acid 1% and sodium thiosulfate 25%) lotion prescribing information. Scottsdale, AZ; 2000 April.

h. Johnson and Johnson. Wart-off (salicylic acid 17%) solution product information. Undated.

i. Schering-Plough. Dr. Scholl’s Callus Remover (salicylic acid 40 %) product information. Memphis, TN. Undated.

j. Bradley/Doak Pharmaceuticals. Trans-Ver-Sal (salicylic acid 15%) wart removal patch product information. Fairfield, NJ; 2005 May.

k. Johnson and Johnson. Aveeno Clear Complexion Cleansing Bar (salicylic acid 0.5%) product information. Skillman, NJ; 2003.

l. Coria Laboratories. Salex (salicylic acid 6%) cream and lotion prescribing information. Fort Worth, TX; Undated.

m. Alva-Amco Pharmacal Co., Inc. Psoriasin Therapeutic Shampoo and Body Wash (salicylic acid 3%) product information. Niles, IL. 2007 Aug

n. Schering-Plough. Dr. Scholl’s Liquid Corn/Callus Remover (salicylic acid 17%) product information. Memphis, TN; Undated.

o. Summers Laboratories. Keralyt gel (salicylic acid 6%) product information. Collegeville, PA. Undated.

p. Pedinol Pharmacal. Hydrisalic gel (salicylic acid 6%) product information. Farmingdale, NY; 2003.

q. Del Pharmaceuticals. Dermarest Psoriasis Medicated Skin Treatment (salicylic acid 3%) product information. Uniondale, NY. Undated.

s. Del Pharmaceuticals. Dermarest Psoriasis Medicated Scalp Treatment (salicylic acid 3%) product information. Uniondale, NY. Undated.

r. Del Pharmaceuticals. Dermarest Psoriasis Medicated Moisturizer (salicylic acid 2%) product information. Uniondale, NY. Undated.

t. Summers Laboratories. Keralyt gel (salicylic acid) product information Collegeville, PA. Undated.

u. Summers Laboratories. Tarsum(salicylic acid 3% and coal tar 2%) shampoo and gel product information. Collegeville, PA; 2002 Oct.

v. Hope Pharmaceuticals. Scottsdale, AZ: Personal communication.

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