Salicylic Acid

• Before you start the treatment, read the manufacturer's printed information leaflet from inside your pack. It will give you more information about the brand of salicylic acid you have been supplied with and how to use it.
• Use salicylic acid exactly as your doctor or pharmacist has recommended. It is usual to apply most preparations once each day.
• If you are using it to remove warts or verrucas, rub off the dead tissue from the top of the wart once a week. You can do this with an emery board, pumice stone or something similar. It may take two weeks or more before you notice any improvement and it can take up to three months of daily applications for warts to go completely.

Take salicylic acid exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Salicylic Acid dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Salicylic Acid is available in the following doses:

• Ammoniated Mercury-salicylic Acid Topical 5%-2.5% Topical Lotion
• Benzoic Acid-salicylic Acid Topical 6%-3% Topical Ointment
• Benzoyl Peroxide-salicylic Acid Topical 4%-1% Topical Pad
• Benzoyl Peroxide-salicylic Acid Topical 5%-2% Topical Pad
• Benzoyl Peroxide-salicylic Acid Topical 8%-2% Topical Pad
• Coal Tar-salicylic Acid Topical 10%-1%-3% Topical Shampoo
• Coal Tar-salicylic Acid Topical 10%-5% Topical Shampoo
• Coal Tar/lactic Acid/salicylic Acid Topical 2%-5%-3% Topical Lotion
• Coal Tar/salicylic Acid/sulfur Topical 0.5%-2%-2% Topical Shampoo
• Coal Tar/salicylic Acid/sulfur Topical 1%-2%-2% Topical Shampoo
• Coal Tar/salicylic Acid/sulfur Topical 2%-1.1%-1.5% Topical Lotion
• Coal Tar/salicylic Acid/sulfur Topical 2%-1.1%-1.5% Topical Ointment
• Coal Tar/salicylic Acid/sulfur Topical 5%-1.5%-2% Topical Shampoo
• Coal Tar/salicylic Acid/sulfur Topical 5%-2%-2% Topical Shampoo
• Doxycycline-salicylic Acid Topical 100 Mg-2% Oral And Topical Kit
• Hydrocortisone/salicylic Acid/sulfur Topical 2%-2%-2% Topical Kit
• Pyrithione Zinc-salicylic Acid Topical 1%-2% Topical Shampoo
• Salicylic Acid Topical 0.5% Topical Liquid
• Salicylic Acid Topical 0.5% Topical Pad
• Salicylic Acid Topical 1% Topical Bar
• Salicylic Acid Topical 1% Topical Pad
• Salicylic Acid Topical 1% Topical Soap
• Salicylic Acid Topical 1.8% Topical Lotion
• Salicylic Acid Topical 1.8% Topical Shampoo
• Salicylic Acid Topical 12% Topical Liquid
• Salicylic Acid Topical 13.6% Topical Liquid
• Salicylic Acid Topical 15% Topical Film, Extended Release
• Salicylic Acid Topical 16.7% Topical Liquid
• Salicylic Acid Topical 17% Topical Film, Extended Release
• Salicylic Acid Topical 17% Topical Gel
• Salicylic Acid Topical 17% Topical Liquid
• Salicylic Acid Topical 17.6% Topical Liquid
• Salicylic Acid Topical 2% Topical Bar
• Salicylic Acid Topical 2% Topical Foam
• Salicylic Acid Topical 2% Topical Gel
• Salicylic Acid Topical 2% Topical Lotion
• Salicylic Acid Topical 2% Topical Pad
• Salicylic Acid Topical 2% Topical Shampoo
• Salicylic Acid Topical 2% Topical Soap
• Salicylic Acid Topical 20% Topical Liquid
• Salicylic Acid Topical 26% Topical Solution
• Salicylic Acid Topical 27.5% Topical Liquid
• Salicylic Acid Topical 3% Topical Gel
• Salicylic Acid Topical 3% Topical Liquid
• Salicylic Acid Topical 3% Topical Lotion
• Salicylic Acid Topical 3% Topical Ointment
• Salicylic Acid Topical 3% Topical Shampoo
• Salicylic Acid Topical 3% Topical Soap
• Salicylic Acid Topical 4% Topical Shampoo
• Salicylic Acid Topical 40% Topical Pad
• Salicylic Acid Topical 5% Topical Gel
• Salicylic Acid Topical 5% Topical Ointment
• Salicylic Acid Topical 6% Topical Cream
• Salicylic Acid Topical 6% Topical Foam
• Salicylic Acid Topical 6% Topical Gel
• Salicylic Acid Topical 6% Topical Kit
• Salicylic Acid Topical 6% Topical Lotion
• Salicylic Acid Topical 6% Topical Shampoo
• Salicylic Acid Topical 6% With Cleanser Topical Kit
• Salicylic Acid Topical 6% With Cleanser Topical Lotion
• Salicylic Acid Topical Compounding Powder
• Salicylic Acid Topical Topical Lotion
• Salicylic Acid-sodium Thiosulfate Topical 1%-25% Topical Lotion
• Salicylic Acid-sulfur Topical 1.5%-2% Topical Soap
• Salicylic Acid-sulfur Topical 2%-2% Topical Lotion
• Salicylic Acid-sulfur Topical 2%-2% Topical Shampoo
• Salicylic Acid-sulfur Topical 2%-2% Topical Soap
• Salicylic Acid-sulfur Topical 3%-10% Topical Soap
• Salicylic Acid-sulfur Topical 3%-5% Topical Shampoo
• Salicylic Acid-sulfur Topical Topical Cream
• Salicylic Acid-urea Topical 5%-10% Topical Ointment
• Salicylic Acid-urea Topical 6%-35% Topical Kit
• Salicylic Acid-urea Topical 6%-40% Topical Foam
• Salicylic Acid-urea Topical Topical Cream

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

• 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.)

Salicylic Acid 6% Cream contains 6% Salicylic Acid USP incorporated into a specially formulated  oil and water emulsion vehicle consisting of Ammonium Lactate, Cetyl Alcohol, Dimethicone, Disodium EDTA, Glycerin, Methyl Paraben, Mineral Oil, PEG-100 , Phenoxy Ethanol, Polysorbate – 80, Propyp Paraben, Trolamine, Water

Salicylic Acid 6% Lotion contains 6% w/w Salicylic Acid USP incorporated into a specially formulated oil and water emulsion vehicle consisting of Ammonium lactate, Cetyl Alcohol, Cetearyl alcohol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Methyl Paraben, Mineral Oil, PEG-100, Phenoxy Ethanol, Polysorbate-80, Propyl Paraben, Trolamine , Water

For Dermatologic  Use: Salicylic Acid 6% is 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, pityriasis rubra pilaris, and  psoriasis (including body, scalp, palms and soles).

For Podiatric Use: Salicylic  Acid 6% is a topical aid in the removal of excessive keratin on  dorsal and plantar hyperkeratotic  lesions. Topical preparations of 6% Salicylic Acid have been reported to be useful adjunctive therapy for verrucae plantares.

Prolonged use over large areas, especially in children and those patients with significant renal or hepatic impairment could result in salicylism. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of Salicylic Acid toxicity, the use of Salicylic Acid 6% should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate.

Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to Salicylic Acid.

Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Patients should be advised not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to Salicylic Acid. Excessive application of the product other than what is needed to cover the affected area will not result in a more rapid therapeutic benefit.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by physician.

The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% is not known.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No data are available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6%. It has been shown to lack mutagenic potential in the Ames test.

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