Salkera Foam

SALKERA® Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based emollient foam vehicle. Each gram of SALKERA Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.

Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following structure:

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. 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 SALKERA Emollient Foam 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.

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 a physician.

Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).

See Warnings.

SALKERA Emollient Foam is supplied in 60g (NDC# 16781-167-60) and 100g (NDC#16781-167-96) aluminum cans.

Store at room temperature 59º - 77ºF (15º - 25ºC) Protect from freezing Store upright.

Manufactured for:

Onset Therapeutics
Cumberland, RI 02864

www.onsettx.com
(888) 713-8154

Patent Pending
P/N 2605 Rev. 2

Rx Only

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.