Document
DailyMed Label: Salvax
Title
DailyMed Label: Salvax
Date
2022
Document type
DailyMed Prescription
Name
Salvax
Generic name
salicylic acid
Manufacturer
Exeltis USA Dermatology, LLC
Product information
NDC: 23710-006
Product information
NDC: 23710-006
Product information
NDC: 23710-006
Product information
NDC: 23710-006
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.
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the following chemical structure:
Chemical Structure
Indications
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.
SALVAX is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.
Dosage
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
Contraindications
SALVAX should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.
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.
(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 T
3 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 FeCl
3 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
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.
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.
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.
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 T
3 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 FeCl
3 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
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.
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.
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 ).
The mechanism of action of topically applied salicylic acid has been attributed to the dissolution of intercellular cement substance.
Package 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
1 organization
2 products
Product
Product BOrganization
Exeltis USA Dermatology, LLCProduct
Salicylic Acid 10%