Salicate

Salicate is an FDA-registered drug product whose active ingredient is SALICYLIC ACID 10%. It is labelled by PureTek Coproration taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 59088-214, label effective 20231013. It is one of 2 FDA drug label records sharing the active ingredient SALICYLIC ACID 10%. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing SALICYLIC ACID 10% are most often described in connection with: salicate topical, excessive keratin, indications usage, hyperkeratotic skin, disorders including, various ichthyoses, keratosis palmaris, pilaris pityriasis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Indications & Usage: For dermatologic Use Salicate™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis. For Podiatric Use Salicate™ is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.

Dosage & Administration: Clean and dry affected area of skin, then apply Salicate™ ™ serum over the affected skin once daily, or as directed by healthcare provider. Apply serum using a gauze or cotton pad evenly across treatment area using circular motions. Allow serum to work on the skin for 1 min or less. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. You will experience a stinging or tingling sensation. If excessive stinging or discomfort occurs, neutralize the serum by flushing the skin with cool water. Redness may occur for a short period of time, especially for those with sensitive skin types. If redness persists longer than 20-30 minutes, decrease the contact time of the serum or discontinue use. Stop Use and Ask a Doctor If • Excessive facial irritation or redness occurs 48-72 hours after application • Chest pain, faintness, or dizziness occurs • You experience pain, swelling, or severe burns • You experience an allergic reaction • Your skin becomes infected • If swallowed, seek medical help or contact a Poison Control Center Immediately *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to treat, cure, prevent, mitigate or diagnose any disease or effect the structure or function of the human body.

Contraindications Section: Salicate™ should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.

Warnings: Salicate™ is for external use only. It is not for ophthalmic, oral, anal, or intravaginal use. Contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided. Salicate™ should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients. 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 should be monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, psychic disturbances. In the event of salicylic acid toxicity, Salicate™ should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Considering the potential risk of developing Reye's syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician. When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Applying the serum more than once per week will increase the risk of skin sensitivity.

Adverse Reactions: Transient stinging, burning, itching or irritation is possible. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician.

FDA lists 2 drug label records with SALICYLIC ACID 10% as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Salicate used for?
Indications & Usage: For dermatologic Use Salicate™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis. For Podiatric Use Salicate™ is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.

Who makes Salicate?
PureTek Coproration is the labeler of record for Salicate. 2 FDA label records share the active ingredient SALICYLIC ACID 10%, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Salicate come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Salicate prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SALICYLIC ACID 10%?
Yes. 2 FDA drug label records list SALICYLIC ACID 10% as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Salicate been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.