Salicylic acid is used alone or in combination with other drugs (e.g., resorcinol, sulfur) for the symptomatic treatment of acne.
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.
Cream, lotion, and gel (6% salicylic acid) used to aid in the exfoliation of dry, scaly skin associated with psoriasis.
Hyperkeratosis
Salicylic acid is used topically as self-medication for its keratolytic and caustic effect in the removal of common and plantar warts; also used to remove corns and calluses.
Salicylic acid is used for treatment of localized hyperkeratosis that occurs on the palms and soles.
Consult a clinician prior to initiating self-medication for a condition that covers a large area of the body.
Administration
Topical Administration
Apply topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, or solution.
For external use only; not for ophthalmic, oral, or intravaginal use. If contact with the eye(s) occurs, wash thoroughly with water.
Rinse hands thoroughly after topical application, unless hands are being treated.
Do not use systemically because of severe irritating effect on GI mucosa and other tissues.
Apply salicylic acid 6% cream (Salex®), lotion (Salex®), or gel (Keralyt®, Hydrisalic®) topically to affected area(s) at bedtime. Hydrate affected area of skin (e.g., with wet packs or baths) for ≥5 minutes prior to application and cover with occlusive dressing. In the morning, wash affected area of skin; may apply a bland emollient if affected skin is irritated or excessively dry. If occlusion is not possible, may 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.)
Acne (Self-medication)
Apply topically using appropriate preparations containing salicylic acid 0.5–2%.
Cleanse and dry the affected area prior to topical application.
Apply a thin layer of appropriate salicylic acid preparation (e.g., cream, gel, lotion) to affected areas.
Apply cake or cleansing solution with water, in place of regular soap; rinse thoroughly with warm water and pat dry.
Seborrheic Dermatitis and Psoriasis (Self-medication)
Apply topically using appropriate preparations containing salicylic acid 1.8–3%.
Apply cream, lotion, ointment, gel, or solution to affected areas of skin.
Apply preparations formulated as soaps or shampoo to affected area(s) in place of regular soap or shampoo.
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).
Do not apply on irritated or infected skin.
Cleanse and dry the affected area prior to topical application.
Trim plaster to fit completely over the callus or corn and apply.
Apply a small amount of solution in flexible collodion with an applicator to sufficiently cover corn or callus and allow to dry.
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.
May soak affected area(s) in warm water for 5 minutes to aid in corn or callus removal.
Wart Removal (Self-medication): Apply topically using appropriate preparations containing salicylic acid 12–40% (plaster) or 5–17% (solution in flexible collodion).
Do not use on moles, birthmarks, warts with hair(s) growing from them, genital warts, or warts on the face or mucous membranes.
Do not apply on irritated, reddened, or infected skin.
Cleanse and dry the affected area prior to topical application; may soak affected area(s) in warm water for 5 minutes.
Trim plaster to fit completely over the wart and apply.
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. Ensure that the plaster does not touch unaffected surrounding skin.
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.
Dosage
Pediatric Patients
Acne
Topical
Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily. Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary. If dryness or peeling occurs, reduce application to once daily or every other day.
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.
Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp. Leave lather on scalp for 2 minutes, then rinse thoroughly; repeat if necessary. Use at least twice weekly or as directed by a clinician.
Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing. Allow to remain on scalp for 5 minutes; add water and lather, and then rinse thoroughly. Gradually increase treatment times to 1 hour, or as directed by a clinician. Alternatively, apply to wet hair and lather; allow to remain on scalp for up to 10 minutes, then rinse. Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.
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.
Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap. Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary. Use at least twice weekly or as directed by a clinician.
Children ≥2 years old: Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude. When improvement occurs, apply occasionally to maintain remission. In areas where occlusion is difficult or impossible, apply more frequently.
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. In areas where occlusion is difficult or impossible, apply more frequently.
Self-medication for children >12 years of age: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician.
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. Repeat every 24 hours as needed until wart is completely removed or for up to 12 weeks.
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.
Adults
Acne
Topical
Self-medication: Apply appropriate 0.5–2% salicylic acid preparation 1–3 times daily. Initially, apply once daily, then gradually increase to 2 or 3 times daily, if necessary. If dryness or peeling occurs, reduce application to once daily or every other day.
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.
Self-medication: Apply 2–3% salicylic acid shampoo to wet hair and massage into scalp. Leave lather on for several minutes, then rinse thoroughly; repeat if necessary. Use at least twice weekly or as directed by a clinician.
Apply combination (salicylic acid and coal tar) shampoo to scalp evenly before bathing. Allow to remain on scalp for 5 minutes and then rinse thoroughly. Gradually increase treatment times to 1 hour, or as directed by a clinician. Alternatively, apply to wet hair; allow to remain on scalp for up to 10 minutes, then rinse. Use daily until itching and flaking improve, then reduce to twice weekly or as directed by a clinician.
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.
Self-medication: Apply 2–3% salicylic acid shampoo to affected area(s) of the body in place of soap. Leave lather on for 2 minutes, then rinse thoroughly; repeat if necessary. Use at least twice weekly or as directed by a clinician.
Apply 6% salicylic acid gel, cream, or lotion to affected area(s) once daily at bedtime and occlude. When improvement occurs, apply occasionally to maintain remission. In areas where occlusion is difficult or impossible, apply more frequently.
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. After 48 hours, remove cushion and plaster. May cover with cushion provided by manufacturer. Repeat every 48 hours as needed until corn or callus is removed, for up to 14 days.
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. Repeat once or twice daily as needed for up to 14 days.
Self-medication: Apply 3% salicylic acid gel to calloused skin once daily or as directed by a clinician.
Apply 6% salicylic acid gel, cream, or lotion to the affected area(s) at bedtime and occlude. In areas where occlusion is difficult or impossible, apply more frequently.
Wart Removal
Topical
Self-medication: Apply 12–40% salicylic acid plaster to wart. After 48 hours, remove and repeat as needed until wart is completely removed or for up to 12 weeks.
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). Repeat once or twice daily for up to 12 weeks.
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. Repeat every 24 hours as needed until wart is completely removed for up to 12 weeks.
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.
Prescribing Limits
Pediatric Patients
Acne
Topical
Self-medication: Apply a maximum 3 times daily.
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.
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.
Adults
Acne
Topical
Self-medication: Apply a maximum 3 times daily.
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.
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.
Hyperkeratosis
Corn and/or Callus Removal
Topical
Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 14 days.
Wart Removal
Topical
Self-medication: Apply plaster or solution or gel in flexible collodion a maximum 12 weeks.
Special Populations
Hepatic Impairment
No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.
Renal Impairment
No specific dosage recommendations at this time; however, manufacturer recommends that treatment area should be limited.
Cautions
Contraindications
Known sensitivity to salicylic acid or any other ingredient in the formulation.
6% salicylic acid cream, lotion, and gel: Children <2 years of age.
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. If salicylic acid toxicity occurs, immediately discontinue; administer fluids to promote urinary excretion, and administer sodium bicarbonate (oral or IV) if clinically necessary.
Avoid other salicylates (e.g., aspirin, salicylate athletic creams) to minimize exposure to salicylic acid. (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.
General Precautions
Topical Effects
Possible excessive erythema or scaling if applied to open skin lesions.
If excessive burning, irritation, stinging, or peeling occurs, discontinue use and consult a clinician.
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.
Lactation
Discontinue nursing or the drug. If used by nursing women, avoid applying to the chest area.
Pediatric Use
Salicylic acid 6% cream, lotion, and gel and 15% plaster not recommended in children <2 years of age. (See Contraindications.)
Increased risk of salicylate toxicity with prolonged, excessive use in children <12 years of age. Limit treatment area and monitor for possible signs of salicylate toxicity. (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. 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.
Hepatic Impairment
Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial hepatic impairment. Limit treatment area and monitor for possible signs of salicylate toxicity. (See Salicylate Toxicity under Cautions.)
Renal Impairment
Possible salicylate toxicity after prolonged topical use over large areas, especially in patients with substantial renal impairment. Limit treatment area and monitor for possible signs of salicylate toxicity. (See Salicylate Toxicity under Cautions.)
Common Adverse Effects
Erythema, scaling, burning, stinging, peeling.
Interactions
Topical Acne Preparations
Cumulative irritant or drying effect. If excessive dryness occurs, use only one topical medication unless directed by a clinician.
Topical Salicylate Preparations
Increased risk of salicylate toxicity.
Protein-bound Drugs
Potential for salicylate to displace or to be displaced by other protein-bound drugs.
Specific Drugs
Drug
Interaction
Comments
Acidifying agents
Drugs that decrease urine pH may decrease salicylate excretion
Rapidly and well absorbed percutaneously following topical application.
Following topical application of salicylic acid 6% gel, >60% absorbed, with peak plasma concentration usually attained within 5 hours (under occlusion).
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.
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 in 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
Cream, Lotion
20–25°C. Do not freeze.
Store combination lotion (salicylic acid 1% and sodium thiosulfate 25%) at 15–30°C.
Solution
Solution in flexible collodion: Tightly closed containers at 15–30°C. Flammable; keep away from heat and open flame.
Gel
Tightly closed containers at 15–30°C.
Gel in flexible collodion: Tightly closed containers at 15–30°C. Flammable, keep away from heat and open flame.
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.
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.
May promote the penetration of other active ingredients and have a comedolytic effect.
Requires moisture to exert its action on the skin and for maceration and desquamation of epidermal tissue.
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.
Importance of rinsing hands thoroughly after topical application, unless hands are being treated.
Advise patients that salicylic acid topical preparations used concurrently with other topical medications may increase skin dryness or irritation.
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.
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.
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.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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