Home > Drugs A-Z > Salvax

Salvax (Quinnova Pharmaceuticals, Inc.)

Available Formats

Dosage Form Package Information Links
AEROSOL, FOAM 70 g in 1 CANISTER (23710-006-70) Label Information
AEROSOL, FOAM 200 g in 1 CANISTER (23710-006-02) Label Information
AEROSOL, FOAM 22 g in 1 CANISTER (23710-006-20) Label Information
AEROSOL, FOAM 10 g in 1 CANISTER (23710-006-01) Label Information

Complete Salvax Information

  • SPL UNCLASSIFIED SECTION

    salicylic acid, 6%

    For Topical Dermatological Use Only

    Hydrating Topical Foam

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

    Rx Only


  • 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

  • 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.


  • INDICATIONS AND USAGE

    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.)

    1. 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
    2. 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
    3. 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

    Pregnancy (Category C)

    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.


  • KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.


  • 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

  • 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.


  • SPL UNCLASSIFIED SECTION

    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


  • 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

  • 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

  • INGREDIENTS AND APPEARANCE
    SALVAX 
    salicylic acid aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23710-006
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 3.88 g  in 70 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTANE (UNII: 6LV4FOR43R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23710-006-70 1 in 1 CARTON 01/01/2009
    1 70 g in 1 CANISTER; Type 0: Not a Combination Product
    2 NDC:23710-006-02 1 in 1 CARTON 01/01/2009
    2 200 g in 1 CANISTER; Type 0: Not a Combination Product
    3 NDC:23710-006-01 1 in 1 CARTON 01/01/2009
    3 10 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/01/2009
    Labeler - Exeltis USA Dermatology, LLC (078715346)
    Establishment
    Name Address ID/FEI Business Operations
    DPT Laboratories, Lts 832224526 MANUFACTURE(23710-006) , LABEL(23710-006)