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Salicylic Acid (Topical)


VA CLASSIFICATION
{20}Salicylic Acid Cream
Primary: DE500

Salicylic Acid Gel
Primary: DE500
Secondary: DE752; DE802

Salicylic Acid Lotion
Primary: DE500
Secondary: DE752; DE900

Salicylic Acid Ointment
Primary: DE500
Secondary: DE752; DE802; DE900

Salicylic Acid Pads
Primary: DE500
Secondary: DE752

Salicylic Acid Plaster
Primary: DE500

Salicylic Acid Shampoo
Primary: DE500
Secondary: DE900

Salicylic Acid Soap
Primary: DE500
Secondary: DE752

Salicylic Acid Topical Solution
Primary: DE500
Secondary: DE752


Commonly used brand name(s): Antinea; Buf-Puf Acne Cleansing Bar with Vitamin E; Calicylic Creme; Clear Away; Clear by Design Medicated Cleansing Pads; Clearasil Clearstick Maximum Strength Topical Solution; Clearasil Clearstick Regular Strength Topical Solution; Clearasil Double Textured Pads Maximum Strength; Clearasil Double Textured Pads Regular Strength; Clearasil Medicated Deep Cleanser Topical Solution; Compound W Gel; Compound W Liquid; Cuplex Gel; Duofilm; Duoplant Topical Solution; Freezone; Gordofilm; Hydrisalic; Ionax Astringent Skin Cleanser Topical Solution; Ionil Plus Shampoo; Ionil Shampoo; Keralyt; Keratex Gel; Lactisol; Listerex Golden Scrub Lotion; Listerex Herbal Scrub Lotion; Mediplast; Noxzema Anti-Acne Gel; Noxzema Anti-Acne Pads Maximum Strength; Noxzema Anti-Acne Pads Regular Strength; Occlusal Topical Solution; Occlusal-HP Topical Solution; Off-Ezy Topical Solution Corn & Callus Remover Kit; Off-Ezy Topical Solution Wart Removal Kit; Oxy Clean Extra Strength Medicated Pads; Oxy Clean Extra Strength Skin Cleanser Topical Solution; Oxy Clean Medicated Cleanser; Oxy Clean Medicated Pads Maximum Strength; Oxy Clean Medicated Pads Regular Strength; Oxy Clean Medicated Pads Sensitive Skin; Oxy Clean Medicated Soap; Oxy Clean Regular Strength Medicated Cleanser Topical Solution; Oxy Clean Regular Strength Medicated Pads; Oxy Clean Sensitive Skin Cleanser Topical Solution; Oxy Clean Sensitive Skin Pads; Oxy Night Watch Maximum Strength Lotion; Oxy Night Watch Night Time Acne Medication Extra Strength Lotion; Oxy Night Watch Night Time Acne Medication Regular Strength Lotion; Oxy Night Watch Sensitive Skin Lotion; Oxy Sensitive Skin Vanishing Formula Lotion; P&S; Paplex; Paplex Ultra; Propa pH Medicated Acne Cream Maximum Strength; Propa pH Medicated Cleansing Pads Maximum Strength; Propa pH Medicated Cleansing Pads Sensitive Skin; Propa pH Perfectly Clear Skin Cleanser Topical Solution Normal/Combination Skin; Propa pH Perfectly Clear Skin Cleanser Topical Solution Oily Skin; Propa pH Perfectly Clear Skin Cleanser Topical Solution Sensitive Skin Formula; Sal-Acid Plaster; Sal-Clens Plus Shampoo; Sal-Clens Shampoo; Sal-Plant Gel Topical Solution; Salac; Salacid; Salactic Film Topical Solution; Saligel; Salonil; Sebucare; Stri-Dex Dual Textured Pads Maximum Strength; Stri-Dex Dual Textured Pads Regular Strength; Stri-Dex Dual Textured Pads Sensitive Skin; Stri-Dex Maximum Strength Pads; Stri-Dex Regular Strength Pads; Stri-Dex Super Scrub Pads; Tersac Cleansing Gel; Trans-Plantar; Trans-Ver-Sal; Verukan Topical Solution; Verukan-HP Topical Solution; Viranol; Viranol Ultra; Wart-Off Topical Solution; X-Seb.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Keratolytic (topical)—Salicylic Acid Cream; Salicylic Acid Gel USP; Salicylic Acid Lotion; Salicylic Acid Ointment; Salicylic Acid Pads; Salicylic Acid Plaster USP; Salicylic Acid Shampoo; Salicylic Acid Soap; Salicylic Acid Topical Solution;

Antiacne agent (topical)—Salicylic Acid Gel USP; Salicylic Acid Lotion; Salicylic Acid Ointment; Salicylic Acid Pads; Salicylic Acid Soap; Salicylic Acid Topical Solution;

Antiseborrheic—Salicylic Acid Lotion; Salicylic Acid Ointment; Salicylic Acid Shampoo;

Antipsoriatic (topical)—Salicylic Acid Gel USP; Salicylic Acid Ointment;

Caustic—Salicylic Acid Cream; Salicylic Acid Ointment; Salicylic Acid Plaster USP; Salicylic Acid Topical Solution;

Indications

Accepted

Acne vulgaris(treatment)—Salicylic acid gel, lotion, ointment, pads, soap, and topical solution are indicated as peeling and drying agents in the treatment of acne vulgaris. {81} {82}

Dandruff (treatment)
Dermatitis, seborrheic (treatment) or
Dermatitis, seborrheic, of scalp (treatment)—Salicylic acid lotion and shampoo are indicated to help control scaling of the scalp associated with dandruff and seborrheic dermatitis. Salicylic acid ointment is indicated in the treatment of seborrheic dermatitis.

Psoriasis (treatment)—Salicylic acid gel and ointment are indicated as adjuncts in the treatment of psoriasis.

Hyperkeratotic skin disorders (treatment)—Salicylic acid is indicated as a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses (vulgaris, sex-linked, and lamellar); keratosis palmaris and plantaris; keratosis pilaris; and pityriasis rubra pilaris. It is also indicated as a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Salicylic acid cream, plaster, and topical solution are indicated to treat corns and calluses. {21} {23} {51} Salicylic acid gel, ointment, plaster, and topical solution are indicated to treat common warts; {14} {23} {41} {47} {50} {80} {83} the gel, plaster, and topical solution are indicated to treat plantar warts. {47} {50} {55} {80}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    138.12

Mechanism of action/Effect:

Salicylic acid facilitates desquamation by solubilizing the intercellular cement that binds scales in the stratum corneum, thereby loosening the keratin. This keratolytic effect may provide an antifungal action because removal of the stratum corneum suppresses fungal growth; it also aids in the penetration of other antifungal agents. Salicylic acid also has a mild antiseptic action.


Precautions to Consider

Pregnancy/Reproduction

Pregnancy—
Studies in humans have not been done; however, salicylic acid may be systemically absorbed. There is concern regarding the possibility of the premature closure of the ductus arteriosis. {44} {55} {77}

Studies in rats and monkeys have shown that salicylic acid causes teratogenic effects. The oral dose given to monkeys may represent 6 times the maximum daily human dose of salicylic acid (as supplied in 28 grams of 6% salicylic acid gel) when applied topically over a large body surface.

FDA Pregnancy Category C.

Breast-feeding

Problems in humans have not been documented; however, salicylic acid may be systemically absorbed. {77}

Pediatrics

Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the pediatric population. However, young children may be at increased risk of toxicity because of increased absorption of salicylic acid through the skin and the increased ratio of total body surface area to treated area. {19} {44} In addition, young children may have a lower threshold for skin irritation from salicylic acid. {55} Salicylic acid should not be applied to large areas of the body, for prolonged periods of time, {22} or under occlusion to substantial areas. {55} {77}


Geriatrics


Appropriate studies on the relationship of age to the effects of salicylic acid have not been performed in the geriatric population. However, elderly patients are more likely to have age-related peripheral vascular disease {24} and, therefore, may be more prone to acute inflammation or ulceration of the extremities when they are treated with the 25 or 60% cream, {21} 12 to 17% gel, 25 to 60% ointment, 12 to 50% plaster, and 5 to 27% topical solution. {16} {47} {51}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication. {55}

Abrasive or medicated soaps or cleansers or
Acne preparations or preparations containing a peeling agent such as
Benzoyl peroxide
Resorcinol
Sulfur
Tretinoin or
Acne preparations, topical, other or
Alcohol-containing preparations, topical such as
After-shave lotions
Astringents
Perfumed toiletries
Shaving creams or lotions or
Cosmetics or soaps with a strong drying effect or
Isotretinoin or
Medicated cosmetics or ``cover-ups''    (concurrent use with salicylic acid may cause a cumulative irritant or drying effect, especially with the application of peeling, desquamating, or abrasive agents, resulting in excessive irritation of the skin)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Sensitivity to salicylic acid
For 25 and 60% cream, 25 to 60% ointment, 12 to 50% plaster, 12 to 26% {80} gel, and 5 to 27% topical solution:
Diabetes mellitus or{14}{47}{51}
Peripheral vascular disease{14}{47}{51}    (acute inflammation or ulceration may occur, especially on the extremities)


Inflammation, irritation, or infection of skin{47}{51}


Side/Adverse Effects

Note: The treatment of warts using high concentrations of salicylic acid may cause skin erosion. This erosion may facilitate the spread of the warts. {55}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent or rare
    
Skin irritation, moderate to severe,{55} not present before therapy
    
skin ulceration or erosion —especially when using medication with a high percentage of salicylic acid{55}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Skin irritation, mild, not present before therapy{55}
    
stinging





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose or salicylism
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Confusion
    
dizziness
    
headache, severe or continuing
    
rapid breathing
    
ringing or buzzing in ears, continuing



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Salicylic Acid (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to salicylic acid

Pregnancy—Medication may be absorbed through the skin; studies in animals have shown that salicylic acid causes birth defects when given orally in doses about 6 times the maximum daily human dose applied topically over a large body surface





Use in children—Young children may be at increased risk of toxicity because of increased absorption of salicylic acid through the skin. Salicylic acid should not be applied to large areas of the body, for long periods of time, or under occlusion to substantial areas


Proper use of this medication
» Importance of using medication only as directed {55}

Proper use of occlusive dressing, if prescribed: Understanding exactly how to apply; using only as directed

» Avoiding contact with the eyes and other mucous membranes; if contact occurs, immediately flushing with water for 15 minutes

Washing hands immediately after applying medication, unless hands are being treated

Proper administration

For cream, lotion, or ointment dosage form
Applying enough to cover affected area; rubbing in gently {55}

For gel dosage form
Before using—Applying wet packs to affected area for at least 5 minutes

Applying enough to cover affected area; rubbing in gently

For pad dosage form
Wiping pad over affected area; not rinsing off medication after treatment

For plaster dosage form
Reading patient instructions carefully before using medication

» Not using on irritated, inflamed, or infected skin, or if diabetic or have impaired blood circulation

» Not using on facial, genital, nasal, or oral warts; warts with hair growing from them; moles; or birthmarks

Washing affected area and drying thoroughly; if treating warts, soaking warts in warm water for 5 minutes before drying

Cutting plaster to fit wart, corn, or callus

If treating corns or calluses, repeating application every 48 hours for up to 14 days; soaking corns or calluses in warm water for 5 minutes to assist in removal

If treating warts, depending on product, either applying plaster and repeating every 48 hours or applying plaster at bedtime, leaving in place for at least 8 hours, removing in the morning, and repeating application every 24 hours; repeating application for up to 12 weeks

Checking with doctor if discomfort increases during treatment or persists after treatment

For shampoo dosage form
Before applying—Wetting hair and scalp with lukewarm water

Applying enough to work up lather; rubbing well into scalp for 2 or 3 minutes; rinsing

Applying again; rinsing thoroughly

For soap dosage form
Working up lather with soap, using hot water

Scrubbing entire affected area with a washcloth or facial sponge or mitt {55}

Using in a foot bath—Working up rich suds in hot water; soaking feet for 10 to 15 minutes; patting dry without rinsing

For topical solution dosage form used for acne
Applying medication to cotton ball or pad; wiping over affected area; not rinsing off medication after treatment

For topical solution dosage form used for corns, calluses, or warts
Reading patient instructions carefully before using medication

» Not using near heat or open flame or while smoking

» Not using on irritated, inflamed, or infected skin, or if diabetic or have impaired blood circulation

» Not using on facial, genital, nasal, or oral warts; warts with hair growing from them; moles; or birthmarks

Avoiding inhalation of vapors

Washing affected area and drying thoroughly; if treating warts, warts may be soaked {55} in warm water for 5 minutes before drying

Applying medication one drop at a time to sufficiently cover each wart, corn, or callus; letting dry

If treating warts, repeating procedure once or twice daily for up to 12 weeks

If treating corns or calluses, repeating procedure once or twice daily for up to 14 days

Soaking corns and calluses in warm water for 5 minutes to assist in removal

Checking with doctor if discomfort increases during treatment or persists after treatment

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
» Avoiding simultaneous use (at same site) with other topical acne preparations or preparations containing peeling agents, alcohol-containing preparations, abrasive soaps or cleansers, cosmetics or soaps with drying effect, medicated cosmetics, or other topical skin medication, unless otherwise directed by physician


Side/adverse effects
Signs of potential side effects, especially skin irritation not present before therapy or symptoms of salicylism


General Dosing Information
In young children, use is not recommended on large areas of the body, for prolonged periods of time, or under occlusion to sizable areas of the body. {77}

For the stronger strengths of salicylic acid, such as the 25 and 60% cream, 25 and 60% ointment, 12 to 50% plaster, 12 to 26% gel, and 5 to 27% topical solution
These products are not recommended for use on irritated, inflamed, or infected skin; facial, genital, nasal, or oral warts; warts with hair growing from them; moles; or birthmarks. {47} {51} In addition, these products are not recommended for use on patients with diabetes mellitus or impaired blood circulation. {47} {51} {80}

For the gel dosage form
Before application of the gel, wet packs should be applied to the affected areas for at least 5 minutes in order to enhance its effect.

The method of use usually preferred is application of the gel to the affected area with an occlusive dressing at night.

For the 25 to 60% creams and ointments
Application of these creams or ointments should be made only by a physician.

Caution should be used to avoid getting these creams or ointments on skin surrounding the area being treated.

Following application of these creams or ointments, an occlusive dressing is applied.

For the 12 to 50% plaster dosage form
The affected area should be washed and dried. {47} {51} Warts may be soaked in warm water for 5 minutes before drying. {47}

The plaster should be cut to fit the wart, corn, or callus. {47} {51}

For corns and calluses: Application should be repeated every 48 hours as needed for up to 14 days until corn or callus is removed. {51} The corn or callus may be soaked in warm water for 5 minutes to aid in removal. {51}

For warts: Depending on the product, the plaster should either be applied every 48 hours {47} or applied at bedtime, left in place for at least 8 hours, removed in the morning, and the application repeated every 24 hours. {47} In either case, application should be repeated for up to 12 weeks until wart is removed. {47}

For the 5 to 27% topical solution dosage form for treatment of warts, corns, or calluses
The affected areas should be washed and dried. {47} {51} Warts may be soaked in warm water for 5 minutes before drying. {47}

Medication should be applied one drop at a time to completely cover wart, corn, or callus. {47} {51}

Procedure should be repeated once or twice daily for up to 14 days for corns or calluses or up to 12 weeks for warts, until wart, corn, or callus is removed. {47} {51}

Corns and calluses may be soaked in water for 5 minutes to aid in removal. {51}


Topical Dosage Forms

SALICYLIC ACID CREAM

Usual adult and adolescent dose
Keratolytic (topical)
Topical, to the skin, as a 2 to 10% cream.

Caustic
Topical, to the skin, as a 25 to 60% cream once every three to five days, under occlusion. {21}


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


2% (OTC) [Propa pH Medicated Acne Cream Maximum Strength{38}{59}]


3% (OTC) [Antinea (benzoic acid 6%){40}]


10% (OTC) [Calicylic Creme{38}{39}]


25% (Rx)[Generic]


60% (Rx)[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID GEL USP

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as a 0.5 to 5% gel once a day.

Antipsoriatic (topical)
Topical, to the skin, as a 5% gel once a day.

Keratolytic (topical)
Topical, to the skin, as a 5 to 26% {01} gel once a day, preferably under occlusion. {80}


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


0.5% (OTC) [Noxzema Anti-Acne Gel{62}]


5% (OTC) [Saligel{38} (alcohol 14%)]


6% [Hydrisalic{39} (OTC)] [Keralyt{39} (OTC) (alcohol 19.4%)] [Keratex Gel{64} (Rx)]


12% (Rx) [Viranol{39}{40} (alcohol)]


17% (OTC) [Compound W Gel{39}]


26% (Rx) [Viranol Ultra{80} (alcohol)]

Canada—


10% (OTC) [Cuplex Gel{61}]


17% (OTC) [Compound W Gel{53}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID LOTION

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as a 1 to 2% lotion one {36} {37} {81} to three times a day. {08}

Antiseborrheic or
Keratolytic (topical)
Topical, to the scalp, as a 1.8 to 2% lotion one or two times a day.


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


1% (OTC) [Oxy Night Watch Sensitive Skin Lotion{37} (cetyl alcohol) (stearyl alcohol)]


1.8% (OTC) [Sebucare]


2% (OTC) [Listerex Golden Scrub Lotion{38}{58}{79}] [Listerex Herbal Scrub Lotion{58}{79}] [Oxy Night Watch Maximum Strength Lotion{36}{38}{81} (cetyl alcohol) (stearyl alcohol)]

Canada—


1% (OTC) [Oxy Night Watch Night Time Acne Medication Regular Strength Lotion{67}]


2% (OTC) [Oxy Night Watch Night Time Acne Medication Extra Strength Lotion{67}] [Oxy Sensitive Skin Vanishing Formula Lotion{67}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.
   • Keep container tightly closed.


SALICYLIC ACID OINTMENT

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as a 3 to 6% ointment.

Antipsoriatic (topical) or
Antiseborrheic or
Keratolytic (topical)
Topical, to the skin, as a 3 to 10% ointment.

Caustic
Topical, to the skin, as a 25 to 60% ointment once every three to five days, under occlusion.


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


25% (Rx) [Salacid{39}]


40% (Rx) [Salonil{39}]


60% (Rx) [Salacid{39}]

Note: Other strengths are currently not commercially available; compounding required for prescriptions.


Canada—
Not commercially available. Compounding required for prescriptions.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID PADS

Usual adult and adolescent dose
Antiacne agent (topical)
Topical, to the skin, as a 0.5 to 2% pad one to {06} {07} {19} three {05} times a day. {82}


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


0.5% (OTC) [Noxzema Anti-Acne Pads Regular Strength{62}] [Oxy Clean Medicated Pads Regular Strength (alcohol 40%){33}{38}] [Oxy Clean Medicated Pads Sensitive Skin (alcohol 22%){34}{66}] [Propa pH Medicated Cleansing Pads Sensitive Skin (alcohol 25%){05}{38}{59}] [Stri-Dex Dual Textured Pads Regular Strength (alcohol 28%){56}] [Stri-Dex Dual Textured Pads Sensitive Skin (alcohol 25%){56}] [Stri-Dex Regular Strength Pads (alcohol 28%){38}{56}{82}]


1% (OTC) [Clear by Design Medicated Cleansing Pads (alcohol 29%){66}]


1.25% (OTC) [Clearasil Double Textured Pads Regular Strength (alcohol 40%){62}]


2% (OTC) [Clearasil Double Textured Pads Maximum Strength (alcohol 40%){62}] [Noxzema Anti-Acne Pads Maximum Strength{62}] [Oxy Clean Medicated Pads Maximum Strength (alcohol 50%){35}{38}] [Propa pH Medicated Cleansing Pads Maximum Strength{59} (alcohol 40%)] [Stri-Dex Dual Textured Pads Maximum Strength{56} (alcohol 44%)] [Stri-Dex Maximum Strength Pads{38}{56} (alcohol 44%)] [Stri-Dex Super Scrub Pads{56} (alcohol 50%)]

Canada—


0.5% (OTC) [Oxy Clean Regular Strength Medicated Pads (alcohol 40%){67}] [Oxy Clean Sensitive Skin Pads (alcohol 22%){67}]


2% (OTC) [Oxy Clean Extra Strength Medicated Pads (alcohol 50%)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID PLASTER USP

Usual adult and adolescent dose
Caustic or
Keratolytic (topical)
Topical, to the skin, as a 12 to 50% plaster every other day or every day. {14} {47} {51} {83}


Usual pediatric dose
See Usual adult and adolescent dose. {14} {77}

Strength(s) usually available
U.S.—


15% (Rx) [Trans-Ver-Sal{83}]


21% (Rx) [Trans-Plantar{40}]


40% (OTC) [Clear Away] [Mediplast{39}]


50% (Rx) [Sal-Acid Plaster{69}]

Canada—


15% (OTC) [Trans-Ver-Sal{41}]

Note: Other strengths are currently not commercially available.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. {17}

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID SHAMPOO

Usual adult and adolescent dose
Antiseborrheic or
Keratolytic (topical)
Topical, to the scalp, as a 2 to 4% shampoo one or two times a week.


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


2% (OTC) [Ionil Plus Shampoo{65}{76}] [Ionil Shampoo (alcohol 12%) (benzalkonium chloride){65}{74}] [P&S] [Sal-Clens Plus Shampoo{63}{72}]


4% (OTC) [Sal-Clens Shampoo{63}{73}] [X-Seb]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well.
   • For external use only.


SALICYLIC ACID SOAP

Usual adult and adolescent dose
Antiacne agent (topical) or
Keratolytic (topical)
Topical, to the skin, as a 2 {03} to 3.5% soap.


Usual pediatric dose
See Usual adult and adolescent dose. {77}

Strength(s) usually available
U.S.—


2% (OTC) [Buf-Puf Acne Cleansing Bar with Vitamin E{78}] [Salac{08}]


3.5% (OTC)[Generic]{38}

Canada—


2% (OTC) [Salac] [Tersac Cleansing Gel{43}{61}]


3.5% (OTC) [Oxy Clean Medicated Soap{67}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • For external use only.


SALICYLIC ACID TOPICAL SOLUTION

Usual adult and adolescent dose
Antiacne agent (topical)
Topical to the skin, as a 0.5 to 2% solution up to three times a day. {25} {75}

Keratolytic (topical)
For warts: Topical, to the skin, as a 5 to 27% solution one or two times a day. {47} {48} {49} {50}

For corns and calluses: Topical, to the skin, as a 12 to 27% solution one or two times a day. {51}


Usual pediatric dose
See Usual adult and adolescent dose . {77}

Strength(s) usually available
U.S.—


0.5% (OTC) [Clearasil Medicated Deep Cleanser Topical Solution (alcohol 43%){62}] [Oxy Clean Medicated Cleanser (alcohol 40%){30}{38}] [Propa pH Perfectly Clear Skin Cleanser Topical Solution Normal/Combination Skin (alcohol 25%){25}{59}] [Propa pH Perfectly Clear Skin Cleanser Topical Solution Sensitive Skin Formula (alcohol 25%){59}]


0.6% (OTC) [Propa pH Perfectly Clear Skin Cleanser Topical Solution Oily Skin (alcohol 51.21%){59}]


1.25% (OTC) [Clearasil Clearstick Regular Strength Topical Solution (alcohol 40%){62}]


1.4% (OTC) [Ionax Astringent Skin Cleanser Topical Solution (isopropyl alcohol) (acetone){65}{75}]


2% (OTC) [Clearasil Clearstick Maximum Strength Topical Solution{62}]


13.6% (OTC) [Freezone (alcohol 20.5%){39}]


16.7% (Rx) [Duofilm] [Gordofilm{39}] [Lactisol{40} (lactic acid 16.7%)] [Salactic Film Topical Solution{69}] [Viranol{39}]


17% [Compound W Liquid (OTC){39}] [Occlusal Topical Solution (OTC) (alcohol 20%){50}] [Off-Ezy Topical Solution Corn & Callus Remover Kit (OTC) (alcohol 21%){60}] [Off-Ezy Topical Solution Wart Removal Kit (OTC) (alcohol 21%){28}{60}] [Paplex (Rx){40}] [Verukan Topical Solution (Rx) (lactic acid 17%) (flexible collodion){64}] [Wart-Off Topical Solution (OTC) (alcohol 26.35%){55}{71}]


26% (Rx) [Occlusal-HP Topical Solution{49}] [Paplex Ultra{40}] [Verukan-HP Topical Solution (flexible collodion){64}]


27% (Rx) [Duoplant Topical Solution (alcohol 50%){40}{48}] [Sal-Plant Gel Topical Solution (alcohol) (lactic acid) (flexible collodion){69}]

Canada—


0.5% (OTC) [Oxy Clean Regular Strength Medicated Cleanser Topical Solution (alcohol 40%){67}] [Oxy Clean Sensitive Skin Cleanser Topical Solution (alcohol 22%){67}]


2% (OTC) [Oxy Clean Extra Strength Skin Cleanser Topical Solution (alcohol 50%)]


17% (OTC) [Compound W Liquid{53}] [Occlusal Topical Solution{57}]


26% (Rx) [Occlusal-HP Topical Solution{57}]

Note: Other strengths are currently not commercially available.


Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a tight container, {47} {51} unless otherwise specified by manufacturer. {18}

Auxiliary labeling:
   • Flammable. {47} {51}
   • For external use only. {47} {51}



Revised: 07/26/1993



References
  1. Compound W Gel package insert (Whitehall Labs—US), Rec 7/87.
  1. Not used.
  1. Salac Cleanser package insert (GenDerm—US), Rec 4/86.
  1. Not used.
  1. Propa pH Medicated Cleansing Pads package insert (Commerce—US), Rec 4/86.
  1. Stri-Dex Pads Regular Strength package insert (Glenbrook—US), Rec 5/87.
  1. Stri-Dex Pads Maximum Strength package insert (Glenbrook—US), Rec 5/87.
  1. Stri-Dex Lotion package insert (Glenbrook—US), Rec 5/87.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Trans-Ver-Sal Transdermal Systems package insert (Minnetonka—US), Rev 11/87, Rec 12/87.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Panel Comments, 9/22/88.
  1. VA classification changes for 1988.
  1. Generic cream 25% & 60% package insert (Pedinol Pharmacal—US), Rec 9/88.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Propa pH Perfectly Clear Skin Cleanser package insert (Commerce—US), PDR for nonprescription drugs 1990: 553.
  1. Not used.
  1. Not used.
  1. Off-Ezy Wart Removal Kit package insert (Commerce—US), PDR for nonprescription drugs 1990: 551.
  1. Not used.
  1. Oxy Clean Medicated Cleanser package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 700.
  1. Not used.
  1. Not used.
  1. Oxy Clean Medicated Pads Regular Strength package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 700.
  1. Oxy Clean Medicated Pads Sensitive Skin package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 700.
  1. Oxy Clean Medicated Pads Maximum Strength package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 700.
  1. Oxy Night Watch Maximum Strength Lotion package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 701.
  1. Oxy Night Watch Sensitive Skin Lotion package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1990: 701.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc. 1992: 547, 549-50.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc. 1992: 600a; 621a.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons, Inc. 1992.
  1. Trans-Ver-Sal Plaster package insert (Westwood—Canada), CPS 1990: 1111.
  1. Not used.
  1. Tersac Cleansing Gel package insert (TCD—Canada), Rev 1988, Rec 6/89.
  1. Profiles: Current antiacne treatment and contraindications in pregnant women. Reaction 26 November 1988.
  1. Not used.
  1. Not used.
  1. Federal Register. Wart remover drug products for over-the-counter human use; final monograph, final rule. Tuesday, August 14, 1990, Part III; 55(157): 33246-56.
  1. Duoplant Topical Solution package insert (Stiefel—US), Rev 7/88, Rec 1/90.
  1. Occlusal-HC Topical Solution package insert (GenDerm—US), Rev 1990, Rec 12/90.
  1. Occlusal Topical Solution package insert (GenDerm—US), Rev 1990, Rec 12/90.
  1. Federal Register. Corn and callus remover drug products for over-the-counter human use; final monograph, final rule. Tuesday, August 14, 1990, Part IV; 55(157): 33258-62.
  1. Not used.
  1. Compound W Gel & Liquid package insert (Whitehall—Canada), CPS 1990: 238.
  1. Not used.
  1. Panel comments, 8/8/91.
  1. Stri-Dex products package inserts (Glenbrook—US), Rec 8/91.
  1. Occlusal products package inserts (Glenbrook—Canada), Rec 8/91.
  1. Listerex products package inserts (Warner-Lambert—US), Rec 8/91.
  1. Propa pH products package inserts (Commerce—US), Rec 8/91.
  1. Off-Ezy products package inserts (Commerce—US), Rec 8/91.
  1. Cuplex Gel and Tersac Cleansing Gel package inserts (Trans CanaDerm—Canada), Rec 8/91.
  1. Clearasil and Noxzema products package inserts (Richardson-Vicks—US), Rec 8/91.
  1. Sal-Clens Plus Soap and Sal-Clens Soap package insert (C&M Pharmacal—US), Rec 8/91.
  1. Keratex Gel, Verukan Topical Solution, and Verukan-HP Topical Solution package inserts (Syosset—US), Rec 8/91.
  1. Ionil and Ionax products package inserts (Owen/Galderma—US), Rec 8/91.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Sal-Clens Plus Shampoo package insert (C & M Pharmacal—US), Rec 9/91.
  1. Sal-Clens Shampoo package insert (C & M Pharmacal—US), Rec 9/91.
  1. Ionil Shampoo package insert (Owen/Galderma—US), Rec 9/91.
  1. Ionax Astringent Skin Cleanser Topical Solution package insert (Owen/Galderma—US), Rec 9/91.
  1. Ionil Plus Shampoo package insert (Owen/Galderma—US), Rec 9/91.
  1. Panel ballot comments 10/31/91.
  1. Buf-Puf Bar Soap package insert (3M—US), Rec 10/91.
  1. Listerex Scrub package insert (Warner-Lambert—US), Rec 11/13/91.
  1. Viranol Ultra package insert (American Dermal—US), PDR 1993: 596.
  1. Oxy Night Watch Maximum Strength Lotion package insert (SmithKline Beecham—US), PDR for nonprescription drugs 1993: 730.
  1. Stri-Dex Dual Textured Pads Regular Strength package insert (Sterling—US), PDR for nonprescription drugs 1993: 756.
  1. Trans-Ver-Sal package insert (Tsumura—US), PDR 1993: 2426.
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