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.

Uses for Salicylic Acid

Acne

Used topically for the management of acne.

Seborrheic Dermatitis, Psoriasis, and Dandruff

Used topically to control seborrheic dermatitis of the body and scalp, psoriasis of the body and scalp, and dandruff.

Hyperkeratosis

Used topically for its keratolytic effect in the removal of common and plantar warts, corns, and calluses.

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

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

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

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.

Administration

Topical Administration

Apply topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, solution, or suspension.

For external use only. Avoid contact with the eyes; if contact occurs, flush thoroughly with water.

Acne

For self-medication, apply topically using appropriate preparation containing salicylic acid 0.5–2%.

Cleanse and dry the affected area prior to topical application.

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

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.

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

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).

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

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

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.

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

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

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).

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

If using a plaster preparation, trim to fit (if necessary).

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.

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. Apply plaster at bedtime.

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

Apply only to wart site and not on surrounding normal skin. Do not apply on irritated, reddened, or infected areas.

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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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. Apply topically to affected area(s) at bedtime and occlude. Wash off in the morning; may apply a bland cream or lotion if affected skin is irritated or excessively dry. In areas where occlusion is not possible, apply more frequently. However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism. (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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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. 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. If bothersome dryness or peeling occurs, reduce application to once daily or every other day.

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.

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

Hyperkeratosis

Corn or Callus Removal

Topical

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

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. Repeat once or twice daily as needed for up to 14 days. If discomfort persists, consult clinician.

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. Response may be seen as early as 2-3 days.

Wart Removal

Topical

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

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. Repeat once or twice daily for up to 12 weeks until wart is removed.

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. Repeat every 24 hours as needed for up to 12 weeks until wart is removed.

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. Repeat once or twice daily as directed by clinician. 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.

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. Apply topically to affected area(s) at bedtime and occlude. Wash off in the morning; may apply a bland cream or lotion if affected skin is irritated or excessively dry. In areas where occlusion is not possible, apply more frequently. However, excessive, repeated application does not necessarily increase therapeutic benefit and may increase risk of adverse local effects and salicylism. (See Salicylate Toxicity under Cautions.)

Cautions for Salicylic Acid

Contraindications

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

• 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.

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.

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. If salicylic acid toxicity occurs, immediately discontinue; administer fluids to promote urinary excretion, and administer sodium bicarbonate (oral or IV) if clinically necessary.

Avoid concomitant use of oral aspirin and other salicylate-containing products (e.g., salicylate athletic creams) to minimize exposure to salicylic acid. (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. Such events occurred within minutes to 24 hours of use, and sometimes required hospitalization. It is not clear whether hypersensitivity was triggered by benzoyl peroxide, salicylic acid, or an inactive ingredient contained in the preparation.

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. 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.

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.

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

For external use only; if product gets into eye, flush with water for 15 minutes.

Topical Effects

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

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

Concomitant Illnesses

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

Specific Populations

Pregnancy

Category C.

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

Lactation

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

Pediatric Use

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

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.

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

Hepatic Impairment

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

Common Adverse Effects

Skin irritation and dryness.

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.

Topical Acne Preparations

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

Protein-bound Drugs

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

Specific Drugs

Salicylic Acid Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed percutaneously following topical application.

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

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.

Distribution

Extent

Distributed into extracellular space.

Plasma Protein Binding

50–80%.

Special Populations

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

Elimination

Elimination Route

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

Stability

Storage

Topical

Tightly closed containers at room temperature. Do not freeze.

Preparations in flexible collodion are flammable; keep away from heat and open flame.

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.

• 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.

• 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.

• Has weak antifungal and antibacterial activity.

Advice to Patients

• Importance of keeping salicylic acid preparations out of reach of children.

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

• For external use only. Importance of avoiding contact with eyes.

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

• 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.

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

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

• Importance of informing patients of other important precautionary information. (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

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Frequently asked questions

• Does duct tape really remove warts?

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