Product Elements:
Salicylic acid salicylic acid dimethicone ethylparaben glycerin methylcellulose (100 cps) phenoxyethanol polyoxyl 40 stearate polysorbate 20 polysorbate 80 povidone sodium citrate sodium hydroxide stearic acid trolamine butane propane salicylic acid salicylic acid
Drug Interactions:
Drug interactions (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% foam is not known.) i. 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 decrease tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding ii. drugs changing salicylate levels by altering renal tubular reabsorption: drug description corticosteroids decreases plasma salicylate level; tapering doses of steroids may promote salicylism ammonium sulfate increases plasma salicylate level iii. drugs with complicated interactions with salicylates: drug description heparin salicylate decreases platelet adhesivesness and interferes with hemostasis in hep
Read more...arin-treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited
Indications and Usage:
Indications and usage for dermatologic use: salicylic acid 6% foam 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: salicylic acid 6% foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
Warnings:
Warnings salicylic acid 6% foam is for external use only. it is not for ophthalmic, oral, anal or intravaginal use. contact with eyes, lips, broken or inflamed skin, and all mucous membranes should be avoided. salicylic acid 6% foam should not be used by persons who have a known hypersensitivity to salicylic acid or any of the 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 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,
Read more...the use of salicylic acid 6% foam should be discontinued. fluids should be administered to promote urinary excretion. treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. condidering the potential of developing reyeâs syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a physician.
General Precautions:
Keep this and all other medications out of the reach of children.
Dosage and Administration:
Unless otherwise directed by a prescribing physician, salicylic acid 6% foam should be applied to the affected area twice a day. salicylic acid 6% foam should be rubbed into the skin until it is completely absorbed. salicylic acid 6% foam should be shaken vigorously before each application and inverted to administer.
Contraindications:
Contraindications salicylic acid 6% foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. salicylic acid 6% foam should not be used in children under 2 years of age.
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 a physician.
Drug Interactions:
Drug interactions (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% foam is not known.) i. 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 decrease tubular reabsorption; clinical toxicity from methotrexate can result oral anticoagulants increased bleeding ii. drugs changing salicylate levels by altering renal tubular reabsorption: drug description corticosteroids decreases plasma salicylate level; tapering doses of steroids may promote salicylism ammonium sulfate increases plasma salicylate level iii. drugs with complicated interactions with salicylates: drug description heparin salicylate decreases platelet adhesivesness and interferes with hemostasis in hep
Read more...arin-treated patients pyrazinamide inhibits pyrazinamide-induced hyperuricemia uricosuric agents effect of probenecid, sulfinpyrazone and phenylbutazone inhibited
Use in Pregnancy:
Pregnancy (category c) - orally administered salicylic acid has been shown to be 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 4 times the maximum daily human dose of salicylic acid (as supplied in one tube, 40 g of salicylic acid 6% gel) when applied topically over a large body surface. there are no adequate and well-controlled studies in pregnant women. salicylic acid 6% foam should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Description:
Description salicylic acid 6% foam is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. each gram of salicylic acid 6% foam contains salicylic acid 6% as the active ingredient, and the following inactive ingredients: dimethicone, ethylparaben, glycerin, methylcellulose, methylparaben, phenoxyethanol, polyoxyl 40 stearate, polysorbate 20, polysorbate 80, povidone, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearic acid and trolamine and in propellants butane and propane.
Clinical Pharmacology:
Salicylic acid has been shown to produce desquamation of the horny layer of skin while not affecting qualitative or quantitative changes in structure of the viable epidermis. the mechanism of action has been attributed to dissolution of intercellular cement substance. in a study of the percutaneous absorption of salicylic acid from salicylic acid 6% foam in four patients with extensive active psoriasis, taylor and halprin showed that peak serum levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. systemic toxic reactions are usually associated with much higher serum leverls (30 to 40 mg/100ml). peak serum levels occurred within 5 hours of the topical application under occlusion. the sites were occluded for 10 hours over the entire body surface below the neck. since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than tho
Read more...se with a normal extracellular space. (see precautions). the major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%), and free salicylic acid (6%). the urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more glucuronides and less salicyluric and salicylic acid. almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space. fifty to eighty percent of salicylate is protein bound to albumin. salicylates compete with the binding of several drugs and can modify the action of these drugs. by similar competetive mechanisms other drugs can influence the serum levels of salicylate. (see precautions).
Pharmacokinetics:
The mechanism of action of topically applied salicylic acid has been attributed to the dissolution of intercellular cement substance.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
No data are available concerning the potential carcinogenic or reproductive effects of salicylic acid 6% foam. it has been shown to lack mutagenic potential in the ames salmonella test.
How Supplied:
Salicylic acid 6% foam is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the ndc# 42192-112-70. store at controlled room temperature 15° - 25°c(59° - 77°f). contains flammable materials. contents under pressure. do not puncture and/or incinerate the containers. do not expose to temperatures over 120°f (48°c) even when empty.
Package Label Principal Display Panel:
Ndc 42192-112-70 salicylic acid 6% foam hydrating topical foam rx only net wt. 2.5 oz (70g) acella pharmaceuticals dosage and administration: apply salicylic acid 6% foam topically to cover affected skin twice per day, or as directed by a physician. rub in until completely absorbed. shake vigorously before each application and invert can to administer. store at room temperature 59degrees to 77 degrees f (15degrees to 15 degrees c) see prescribing information for additional details. ingredients: salicylic acid 6%, dimethicone, ethylparaben, glycerin, methylcellulose, methylparabaen, phenoxyethanol, polyoxyl 40 stearate, polysorbate 20, polysorbate 80, povidone, propylene glycol, propylparaben, purified water, sodium citrate, sodium hydroxide, stearic acid, and trolamine and in propellants butane and propane. warning: contains flammable materials. contents under pressure. do not puncture or incinerate. do not expose to temperatures over 120 degrees f (48 degrees c) even when empty. keep out of reach of children. manufactured for acella pharmaceuticals, llc alpharetta, ga 30009 1-800-541-4802 rev 0909v4
Primary structure