FDA Label for Salvax

Other

salicylic acid, 6%

For Topical Dermatological Use Only

Hydrating Topical Foam

(salicylic acid 6% in a water and lipid based foam)

Rx Only

U.S. Patent 5,993,830.

Manufactured for Exeltis USA Dermatology, LLC. Florham Park, NJ 07932 / (877) 324-9349

Issue Date: July 2016

Exeltis
Rethinking healthcare

www.exeltisUSA.com

0062001-01

Description

SALVAX is applied topically and used in the removal of excessive keratin in hyperkeratotic skin disorders. Each gram of SALVAX 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 as propellants isobutane and propane.

Chemical Structure

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

Chemical Structure - salvax 01

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 SALVAX in four patients with extensive active psoriasis, Taylor and Halprin showed that peak serum salicylate 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 levels (30 to 40 mg/100 ml). 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 those 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 competitive 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.

For Dermatologic Use

SALVAX 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

SALVAX is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.

Contraindications

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

Warnings

SALVAX 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. SALVAX 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, the use of SALVAX 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.

Precautions

SALVAX should be used only as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. SALVAX should not be used on any skin area where inflammation or exudation is present as increased absorption may occur. If redness or irritation occurs, discontinue use and consult with prescribing physician.

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 SALVAX is not known.)

• 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

• 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

• Drugs with complicated interactions with salicylates:

  Drug	Description
  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

The following alterations of laboratory tests have been reported during salicylate therapy:

Laboratory Tests	Effect of Salicylates
Thyroid Function	Decreased PBI; increased T3 uptake
Urinary Sugar	False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5 g qd)
5 Hydroxyindole Acetic Acid	False negative with fluorometric test
Acetone, Ketone Bodies	False positive FeCl3 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 dose
Prothrombin	Decreased levels; slightly increased prothrombin time

Teratogenic Effects

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 when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. SALVAX should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers

It is not known whether topically applied salicylic acid is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering SALVAX to nursing mothers and nursing mothers should certainly not apply SALVAX 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 SALVAX, 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 potential carcinogenic or reproductive effects of SALVAX. It has been shown to lack mutagenic potential in the Ames Salmonella test.

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.

Dosage And Administration

Clean and dry affected skin. Then apply SALVAX topically to cover affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

Shake canister vigorously before each use. Turn upside down (nozzle down) to dispense. Depress ridged portion of dispenser, as illustrated at right.

Figure - salvax 02

How Supplied

SALVAX is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC Number 23710-006-70, a 200 gram or 7.1 ounce aerosolized canister bearing the NDC Number 23710-006-02, and a 10 gram or 0.36 ounce aerosolized canister bearing the NDC Number 23710-006-01. The 10 gram canister is a physician-dispensed sample product.

Storage And Handling

Store at room temperature 15° - 25°C (59° - 77°F).

Contains flammable materials. Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120°F (48°C) even when empty.

Principal Display Panel - 200 G Canister Label

NDC 23710-006-02

SALVAX^®

salicylic acid 6%

HYDRATING TOPICAL FOAM

PRODERM TECHNOLOGY^®

Rx only

NET WT. 7.1 OZ (200 g)

PRINCIPAL DISPLAY PANEL - 200 g Canister Label - salvax 03

Principal Display Panel - 200 G Canister Carton

NDC 23710-006-02

SALVAX^®

salicyclic acid
6%

HYDRATING TOPICAL FOAM
PRODERM TECHNOLOGY^®

Exeltis
Rethinking healthcare

Rx only

NET WT. 7.1 OZ (200 g)

PRINCIPAL DISPLAY PANEL - 200 g Canister Carton - salvax 04