RayaSal SALICYLIC ACID 5.9% RAYA PHARMACEUTICALS LLC FDA Approved RAYASAL is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. Each gram of RAYASAL contains salicylic acid 5.9% as the active ingredient and the following inactive ingredients: cetyl alcohol, disodium EDTA, emulsifying wax, glyceryl stearate SE, jojoba oil, PEG-100 stearate, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, stearic acid, stearyl alcohol, tocopheryl acetate, white petrolatum, xanthan gum.
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Substance Salicylic Acid
Route
TOPICAL
Package NDC

Drug Facts

Composition & Profile

Strengths
5.9 %
Quantities
31548 count
Treats Conditions
For Dermatologic Use Rayasal 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 Rayasal Is A Topical Aid In Removing Excessive Keratin On Dorsal And Plantar Hyperkeratotic Lesions

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0382098009951
UNII
O414PZ4LPZ
Packaging

RAYASAL Salicylic Acid 5.9% Gel is supplied in a 95-gram AIRLESS pump bearing the NDC Number 382098-009-95 Store at a controlled room temperature of 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]; NDC: 382098-009-95 RayaSal salicylic acid 5.9% Topical Cream For Topical Dermatological Use Only, not for ophthalmic, oral, or intravaginal use. RX Only NET WT. 3.35 OZ (95 g) MANUFACTURED FOR RAYA Pharmaceuticals, LLC Kingsland, GA, 31548 1-800-467-1205 REV 1/22 Inner Label Outer Carton

Package Descriptions
  • RAYASAL Salicylic Acid 5.9% Gel is supplied in a 95-gram AIRLESS pump bearing the NDC Number 382098-009-95 Store at a controlled room temperature of 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]
  • NDC: 382098-009-95 RayaSal salicylic acid 5.9% Topical Cream For Topical Dermatological Use Only, not for ophthalmic, oral, or intravaginal use. RX Only NET WT. 3.35 OZ (95 g) MANUFACTURED FOR RAYA Pharmaceuticals, LLC Kingsland, GA, 31548 1-800-467-1205 REV 1/22 Inner Label Outer Carton

Overview

RAYASAL is applied topically and used to remove excessive keratin in hyperkeratotic skin disorders. Each gram of RAYASAL contains salicylic acid 5.9% as the active ingredient and the following inactive ingredients: cetyl alcohol, disodium EDTA, emulsifying wax, glyceryl stearate SE, jojoba oil, PEG-100 stearate, phenoxyethanol, propylene glycol, purified water, sodium hydroxide, stearic acid, stearyl alcohol, tocopheryl acetate, white petrolatum, xanthan gum.

Indications & Usage

For dermatologic Use RAYASAL 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 RAYASAL 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 RayaSal topically over the affected skin twice daily, or as directed by healthcare provider. Rub in until completely fade. The preferable method of use is to apply RAYASAL Cream thoroughly to the affected area and occlude the area at night. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning, and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once the clearing is apparent, the occasional use of RAYASAL Cream will usually maintain the remission. In those areas where occlusion is difficult or impossible, the application may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. Unless hands are being treated, hands should be rinsed thoroughly after application.

Warnings & Precautions
RAYASAL 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. RAYASAL 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, RAYASAL 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.
Contraindications

RAYASAL should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.

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.

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


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