Salicylic Acid (Monograph)

Brand names: AcneFree, Ambi, Aveeno, ClarityMD, Clean and Clear, ... show all 30 brands Clearasil, Compound W, Denorex, Dermarest, DHS Sal, Dr. Scholl’s, DuoFilm, Gordofilm, Hydrisalic, Keralyt, Mediplast, MG217, Neutrogena, Noxzema, Oxy, Paraid, Proactiv, Psoriasin, Salactic, Salex, Sal-Plant, Sebasorb, Stridex, UltraSal-ER, Virasal
Drug class: Keratolytic Agents
ATC class: D01AE12
VA class: DE500
CAS number: 69-72-7

Medically reviewed by Drugs.com on Feb 19, 2024. Written by ASHP.

Introduction

Keratolytic agent; derivative of benzoic acid.^a

Uses for Salicylic Acid

Acne

Used topically for the management of acne.^{100 104 105 113 114 115 118 119 125 126}

Seborrheic Dermatitis, Psoriasis, and Dandruff

Used topically to control seborrheic dermatitis of the body and scalp, psoriasis of the body and scalp, and dandruff.^{103 109 121 127}

Hyperkeratosis

Used topically for its keratolytic effect in the removal of common and plantar warts,^{101 106 107 111 112 116 122 123} corns, and calluses.^{102 110 112}

Salicylic acid 5% in fixed-combination with urea 10% is used to soften and control growth of calluses.¹⁰⁸

Do not use on moles, birthmarks, warts with hair(s) growing from them, genital warts, or warts on the face or mucous membranes.^{101 106 116}

Also used topically for management of other hyperkeratotic skin disorders such as ichthyoses vulgaris, palmoplantar keratosis, pityriasis rubra pilaris, and keratosis pilaris.¹¹⁷

Related/similar drugs

doxycycline, clindamycin topical, erythromycin topical, ketoconazole topical, tetracycline, Temovate, cantharidin topical

Salicylic Acid Dosage and Administration

General

• Salicylic acid is commercially available in various preparations, some of which are intended for self-medication; consult manufacturer’s labeling for complete directions for appropriate dosage and administration of specific products.^{100 101 102 103}

Administration

Topical Administration

Apply topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, solution, or suspension.^{104 105 106 107 108 109 110 111 112 113 114 115 116 117}

For external use only.^{100 101 102 103} Avoid contact with the eyes; if contact occurs, flush thoroughly with water.^{101 102 103}

Acne

For self-medication, apply topically using appropriate preparation containing salicylic acid 0.5–2%.^{100 104 105 113 114 115}

Cleanse and dry the affected area prior to topical application.¹⁰⁰

If using a product that is intended to be applied and removed (e.g., cleanser, soap, mask, scrub), rinse thoroughly with water after application.^{100 104 105}

Seborrheic Dermatitis, Psoriasis, and Dandruff

For self-medication, apply topically using appropriate preparation containing salicylic acid 1.8–3% to affected areas of skin and/or scalp.^{103 109}

Apply preparations formulated as soaps or shampoos to affected area(s) in place of regular soap or shampoo.^{103 109}

Corn and Callus Removal

For self-medication, apply topically using appropriate preparation containing salicylic acid 12–40% (in plaster) or 12–17.6% (in collodion-like vehicle).¹⁰²

Cleanse and dry affected area prior to topical application.¹⁰² May soak affected area(s) in warm water for 5 minutes to aid in removal of the corn or callus.¹⁰²

If using a plaster product, trim plaster (if necessary) to fit over the callus or corn.¹⁰²

If using a product in a collodion-like vehicle, apply small amount (e.g., one drop at a time) with an applicator to sufficiently cover corn or callus and allow to dry.¹⁰²

Kerasal foot ointment (salicylic acid 5% in combination with urea 10%): Gently massage into skin until fully absorbed.¹⁰⁸ For faster results, apply in the evening and cover skin with cotton socks after application.¹⁰⁸

Do not apply on irritated, reddened, or infected areas.¹⁰²

Wart Removal

For self-medication, apply topically using appropriate preparation containing salicylic acid 12–40% (in plaster), 5–17% (in collodion-like vehicle), or 15% (in karaya gum-glycol plaster vehicle).¹⁰¹

Cleanse and dry affected area prior to topical application; may soak affected area(s) in warm water for 5 minutes.¹⁰¹

If using a plaster preparation, trim to fit (if necessary).^{101 112}

If using a preparation in collodion-like vehicle, apply small amount (e.g., one drop at a time) with an applicator to sufficiently cover wart; allow to dry.^{101 107 111}

If using a preparation in karaya gum-glycol plaster, gently smooth wart surface with emery file and apply a drop of warm water to wart prior to application; keep surrounding skin dry.¹⁰¹ Apply plaster at bedtime.¹⁰¹

Salicylic acid 27.5 or 28.5% solution: Prior to application, soak wart in warm water for 5 minutes.^{106 116} Remove any loose tissue by gently rubbing (e.g., with a wash cloth, emery board, or brush); dry thoroughly.^{106 116} Use brush applicator supplied by manufacturer to apply solution; allow to dry.^{106 116}

Apply only to wart site and not on surrounding normal skin.^{106 116} Do not apply on irritated, reddened, or infected areas.¹⁰¹

Dosage

Pediatric Patients

Acne

Topical

Self-medication using a 0.5–2% preparation intended to be applied and left on the skin (e.g., gel, lotion): Apply a thin layer 1–3 times daily.^{100 114 115} To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.^{100 114} If bothersome dryness or peeling occurs, reduce application to once daily or every other day.^{100 114}

Self-medication using a 0.5–2% preparation intended to be applied and removed from the skin (e.g., cleansers, soaps, masks, scrubs): Apply a thin layer to affected area and rinse thoroughly 1–3 times daily.^{100 104 105} To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.^{100 104} If bothersome dryness or peeling occurs, reduce application to once daily or every other day.^{100 104 105}

Self-medication using a 0.5–2% solution-containing pledget (pad): Wipe affected area with 1 pad; may repeat with a clean pad if necessary to remove remaining traces of dirt.¹¹³ To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.¹¹³ If bothersome dryness or peeling occurs, reduce application to once daily or every other day.¹¹³

Hyperkeratosis

Hyperkeratotic Skin Disorders (verrucae, ichthyoses vulgaris, palmoplantar keratosis, keratosis pilaris, pityriasis rubra pilaris, psoriasis [including body, scalp, palms, and soles])

Topical

Salicylic acid 6% cream or lotion in children ≥2 years of age: Hydrate affected area of skin (e.g., with wet packs or baths) for ≥5 minutes prior to application.¹¹⁷ Apply topically to affected area(s) at bedtime and occlude.¹¹⁷ Wash off in the morning; may apply a bland cream or lotion if affected skin is irritated or excessively dry.¹¹⁷ In areas where occlusion is not possible, apply more frequently.¹¹⁷ However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism.¹¹⁷ (See Salicylate Toxicity under Cautions.)

Adults

Acne

Topical

Self-medication using a 0.5–2% preparation intended to be applied and left on the skin (e.g., gel, lotion): Apply a thin layer 1–3 times daily.^{100 114 115} To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.^{100 114} If bothersome dryness or peeling occurs, reduce application to once daily or every other day.^{100 114}

Self-medication using a 0.5–2% preparation intended to be applied and removed from the skin (e.g., cleansers, soaps, masks, scrubs): Apply a thin layer to affected area and rinse thoroughly 1–3 times daily.^{100 104 105} To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.^{100 104} If bothersome dryness or peeling occurs, reduce application to once daily or every other day.^{100 104 105}

Self-medication using a 0.5–2% solution-containing pledget (pad): Wipe affected area with 1 pad; may repeat with a clean pad if necessary to remove remaining traces of dirt.¹¹³ To reduce risk of excessive skin dryness, initially apply once daily, then gradually increase to 2–3 times daily as necessary or directed by clinician.¹¹³ If bothersome dryness or peeling occurs, reduce application to once daily or every other day.¹¹³

Seborrheic Dermatitis, Psoriasis, and Dandruff

Skin and Scalp

Topical

Self-medication using a 1.8–3% salicylic acid cream, ointment, or lotion: Apply to affected area(s) 1–4 times daily or as directed by clinician.¹⁰³

Self-medication using a 1.8–3% salicylic acid shampoo: Apply to wet skin and/or scalp and massage to form a lather.^{103 109} Leave lather on for several minutes, then rinse thoroughly; repeat if necessary.^{103 109} For best results, use at least twice weekly or as directed by clinician.^{103 109}

Hyperkeratosis

Corn or Callus Removal

Topical

Self-medication using a 12–40% salicylic acid plaster: Apply to corn or callus for 48 hours.^{102 112} After 48 hours, remove plaster.^{102 112} Repeat every 48 hours as needed (for up to 14 days) until corn or callus is removed.^{102 112} If discomfort persists, consult clinician.¹⁰²

Self-medication using a 12–17.6% salicylic acid solution or gel in collodion: Apply small amount (e.g., 1 drop at a time) to sufficiently cover corn or callus.^{102 110} Repeat once or twice daily as needed for up to 14 days.^{102 110} If discomfort persists, consult clinician.¹⁰²

Kerasal foot ointment (salicylic acid 5% in combination with urea 10%): Apply sparingly to calloused skin once daily to soften and prevent growth of calluses.¹⁰⁸ Response may be seen as early as 2-3 days.¹⁰⁸

Wart Removal

Topical

Self-medication using a 12–40% salicylic acid plaster: Apply to wart for 48 hours.¹⁰¹ Repeat every 48 hours as needed for up to 12 weeks until wart is removed.¹⁰¹

Self-medication using a 5–17% salicylic acid solution or gel in flexible collodion-like vehicle: Apply small amount (e.g., 1 drop at a time) to sufficiently cover wart.^{101 111} Repeat once or twice daily for up to 12 weeks until wart is removed.^{101 111}

Self-medication using a 15% salicylic acid plaster in a karaya gum and glycol vehicle: Apply to wart at bedtime; leave in place for ≥8 hours, then remove and discard.¹⁰¹ Repeat every 24 hours as needed for up to 12 weeks until wart is removed.¹⁰¹

Salicylic acid 27.5 or 28.5% solution (e.g., UltraSal-ER, Virasal): Using brush applicator supplied, apply twice to entire wart surface; allow first application to dry before applying second.^{106 116} Repeat once or twice daily as directed by clinician.^{106 116} Visible improvement usually occurs during first or second week of therapy with resolution after 4–6 weeks; however, some warts may take longer to resolve.^{106 116}

Hyperkeratotic Skin Disorders (verrucae, ichthyoses vulgaris, palmoplantar keratosis, keratosis pilaris, pityriasis rubra pilaris, psoriasis [including body, scalp, palms, and soles])

Topical

Salicylic acid 6% cream or lotion: Hydrate affected area of skin (e.g., with wet packs or baths) for ≥5 minutes prior to application.¹¹⁷ Apply topically to affected area(s) at bedtime and occlude.¹¹⁷ Wash off in the morning; may apply a bland cream or lotion if affected skin is irritated or excessively dry.¹¹⁷ In areas where occlusion is not possible, apply more frequently.¹¹⁷ However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism.¹¹⁷ (See Salicylate Toxicity under Cautions.)

Cautions for Salicylic Acid

Contraindications

• Known sensitivity to salicylic acid or any other ingredient in the formulation.¹¹⁷

• Salicylic acid 27.5 and 28.5% solutions: Patients with diabetes or impaired circulation; use on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.^{106 116}

Warnings/Precautions

Warnings

Because salicylic acid is rapidly and efficiently absorbed percutaneously following topical application to the skin, adverse effects as a result of systemic exposure to the drug are possible.^{118 120}

Salicylate Toxicity

Although risk is minimal with topical use, salicylate toxicity (e.g., nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, psychosis) is possible after prolonged or excessive use over large areas of the body.^{117 118 120} If salicylic acid toxicity occurs, immediately discontinue; administer fluids to promote urinary excretion, and administer sodium bicarbonate (oral or IV) if clinically necessary.¹¹⁷

Avoid concomitant use of oral aspirin and other salicylate-containing products (e.g., salicylate athletic creams) to minimize exposure to salicylic acid.¹¹⁷ (See Interactions.)

Sensitivity Reactions

Serious Hypersensitivity Reactions

Rare, but serious hypersensitivity reactions (e.g., anaphylaxis, skin irritation, burning, erythema, dermatitis) reported with certain nonprescription (over-the-counter, OTC) topical acne preparations containing salicylic acid or benzoyl peroxide.¹²⁴ Such events occurred within minutes to 24 hours of use, and sometimes required hospitalization.¹²⁴ It is not clear whether hypersensitivity was triggered by benzoyl peroxide, salicylic acid, or an inactive ingredient contained in the preparation.¹²⁴

If any symptoms of a serious hypersensitivity reaction (e.g., hives, itching, throat tightness, difficulty breathing, faintness, swelling of the eyes, face, lips, or tongue) occur, immediately discontinue and avoid future use of the product.¹²⁴ To reduce risk of serious hypersensitivity reactions, FDA recommends sensitivity testing (e.g., application of a small amount for 3 days) prior to first use of a topical acne preparation.¹²⁴

General Precautions

Administration Precautions

Consult a clinician prior to initiating self-medication for the control of seborrheic dermatitis or psoriasis if condition covers a large area of the body.^{103 109}

When used for self-medication of seborrheic dermatitis, psoriasis, or dandruff, consult a clinician if condition worsens or does not improve after regular use.¹⁰³

For external use only; if product gets into eye, flush with water for 15 minutes.^{100 101 102 103}

Topical Effects

Possible excessive erythema or scaling if applied to open skin lesions.¹¹⁷

When applying wart removal preparations, avoid contact with normal skin surrounding wart; local irritation may occur.^{106 116} Discontinue treatment if excessive irritation occurs.^{106 116}

Concomitant Illnesses

Do not use salicylic acid wart, corn, and callus removal preparations in patients with diabetes or with poor blood circulation.^{101 107}

Specific Populations

Pregnancy

Category C.¹¹⁷

No adequate and well-controlled studies in pregnant women; use during pregnancy only if potential benefits justify possible risks to fetus.¹¹⁷

Lactation

Discontinue nursing or drug.¹¹⁷ If used in nursing women, avoid applying to chest area to avoid contaminating infant.¹¹⁷

Pediatric Use

Because of a greater risk of systemic absorption and toxicity, some experts recommend that salicylic acid be avoided in children.¹²⁷ Some manufacturers state that use of salicylic acid is contraindicated in pediatric patients <2 years of age.¹¹⁷

Manufacturers of some topical salicylic acid preparations for the treatment of psoriasis or seborrheic dermatitis state that the drug is intended for self-medication in normal healthy adults only; use in pediatric patients <18 years of age should be under the direction of a clinician.¹⁰⁹

Salicylates should not be used in children and adolescents with varicella infection or influenza because of an increased risk of developing Reye’s syndrome.¹¹⁷

Hepatic Impairment

Prolonged and repeated topical use over large areas in patients with substantial hepatic impairment may cause salicylate toxicity.¹¹⁷ Limit treatment area and monitor for possible signs of salicylate toxicity in patients with hepatic impairment.¹¹⁷ (See Salicylate Toxicity under Cautions.)

Renal Impairment

Prolonged and repeated topical use over large areas in patients with substantial renal impairment may cause salicylate toxicity.¹¹⁷ Limit treatment area and monitor for possible signs of salicylate toxicity in patients with renal impairment.¹¹⁷ (See Salicylate Toxicity under Cautions.)

Common Adverse Effects

Skin irritation and dryness.¹⁰⁰

Drug Interactions

Because salicylic acid is rapidly and efficiently absorbed percutaneously following topical application to the skin, drug interactions as a result of systemic exposure to the drug are possible.¹¹⁸

Topical Acne Preparations

Cumulative irritant or drying effect.¹⁰⁰ If irritation occurs, use only one topical acne medication at a time.¹⁰⁰

Protein-bound Drugs

Potential for salicylate to displace or to be displaced by other protein-bound drugs.¹¹⁷

Specific Drugs

Salicylic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed percutaneously following topical application.^{117 118}

Bioavailability of topical salicylic acid varies according to duration of contact and vehicle.^{118 120} Absorption has ranged from 9 to >60%.^{117 118} Following topical application of salicylic acid 6% gel with occlusion, >60% absorbed, with peak plasma concentrations usually attained within 5 hours.¹¹⁷

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.¹¹⁷

Distribution

Extent

Distributed into extracellular space.¹¹⁷

Plasma Protein Binding

50–80%.¹¹⁷

Special Populations

Patients with a contracted extracellular space secondary to dehydration or diuretics may have increased plasma salicylate levels.¹¹⁷

Elimination

Elimination Route

Excreted principally in urine as salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%).¹¹⁷

Stability

Storage

Topical

Tightly closed containers at room temperature.^{106 116 117} Do not freeze.¹¹⁷

Preparations in flexible collodion are flammable; keep away from heat and open flame.^{101 102 107 110 111}

Actions

• Topical keratolytic agent that produces desquamation of the horny layer (stratum corneum) of skin by dissolving the intercellular cement that holds epithelial cells together.^{117 118 120}

• Exact mechanism(s) of action in the treatment of warts not elucidated; keratolytic activity may result in mechanical removal of epidermal cells infected with wart viruses.^{106 116}

• 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

Advice to Patients

• Importance of keeping salicylic acid preparations out of reach of children.^{104 105 107}

• Importance of avoiding heat or flames during use of certain salicylic acid collodion formulations.¹⁰⁷

• For external use only.^{101 102 103} Importance of avoiding contact with eyes.^{101 102 103}

• Advise patients that salicylic acid topical preparations used concurrently with other topical acne medications may increase skin dryness or irritation.¹⁰⁰

• When used 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.^{103 109}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹¹⁷

• Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹¹⁷

• Importance of informing patients of other important precautionary information.¹¹⁷ (See Cautions.)

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

Frequently asked questions

• Does duct tape really remove warts?

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