Salicylic Acid 10%
FDA Drug Information • Also known as: Salicate, Tag Wart Remover
- Brand Names
- Salicate, Tag Wart Remover
- Route
- TOPICAL
- Dosage Form
- LIQUID
- Product Type
- HUMAN OTC DRUG
Description
Description: Salicate™ is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. Each gram of Salicate™ contains salicylic acid 10% as the active ingredient and the following inactive ingredients: Aqua (Water Purified), Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Glycerin, Hydroxyethylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Symphytum Officinale (Comfrey) Leaf Extract.
What Is Salicylic Acid 10% 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.
Dosage and Administration
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
Side Effects (Adverse Reactions)
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.
Warnings and Precautions
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.
Drug Interactions
Drug Interactions: The following interactions are from a published review 5 and include reports concerning oral and topical salicylate administration. The relationship of these interactions to the use of SALICYLIC ACID is not known. A. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: Drug Description of Interaction Tolbutamide; Sulfonylureas Hypoglycemia potentiated Methotrexate Decreases tubular reabsorption; clinical toxicity from methotrexate can result Oral Anticoagulants Increased bleeding B. Drugs changing salicylate levels by altering renal tubular reabsorption: Drug Description of Interaction Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism Ammonium Sulfate Increases plasma salicylate level C. Drugs with complicated interactions with salicylates: Drug Description of Interaction Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia Uricosuric Agents Effect of probenecid, sulfinpyrazone, and phenylbutazone inhibited D. The following alterations of laboratory tests have been reported during salicylate therapy: 6 Laboratory Tests Effect of Salicylates Thyroid Function Decreased PBI; increased T uptake Urinary Sugar False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g qd) 5 Hydroxyindole Acetic Acid False negative with fluorometric test Acetone, Ketone Bodies False positive FeCl in Gerhardt reaction; red color persists with boiling 17-OH corticosteroids False reduced values with >4.8 g qd salicylate Vanilmandelic Acid False reduced values Uric Acid May increase or decrease depending on the dose Prothrombin Decreased levels; slightly increased prothrombin time
Contraindications
Contraindications Section: Salicate™ should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.
Pregnancy and Breastfeeding
Pregnancy: Pregnancy (Category C) Salicylic acid is teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent four times the Maximum daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicate™ should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Nursing Mothers It is unknown whether topically applied salicylic acid is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised by physicians when administering Salicate™ to nursing mothers and nursing mothers should certainly not apply Salicate™ to the chest area or any other part of the body with which the nursing child's mouth is likely to come in contact. Because of the potential for serious adverse reactions in nursing infants from the mother's use of Salicate™ , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available concerning the potential carcinogenic or reproductive effects of Salicate™ . It has been shown to lack mutagenic potential in the Ames Salmonella test.
How Supplied
How Supplied: Salicate™ is a serum supplied in a 1 fl oz Bottle. NDC 59088-214-03
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.