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SALICYLIC ACID (Acella Pharmaceuticals, LLC)

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AEROSOL, FOAM 70 g in 1 CANISTER (42192-112-70) Label Information

Complete SALICYLIC ACID Information

  • 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.


  • SPL UNCLASSIFIED SECTION

    CHEMICAL STRUCTURE

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

    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 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 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
    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.


  • INDICATIONS & 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.


  • 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.


  • 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, 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 Reye’s syndrome, salicylate products should not be administered to children or teenagers with varicella or influenza, unless directed by a
    physician.


  • PRECAUTIONS

    PRECAUTIONS 
    Salicylic Acid 6% Foam 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. Salicylic Acid 6%
    Foam 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

    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

    heparin-treated patients

    Pyrazinamide Inhibits pyrazinamide-induced hyperuricemia

    Uricosuric Agents Effect of probenecid, sulfinpyrazone and phenylbutazone inhibited


  • LABORATORY TESTS


    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 salicylat
                                                                                                                                     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

    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.


  • NURSING MOTHERS

    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 Salicylic Acid 6% Foam to nursing mothers and nursing mothers should certainly not apply Salicylic Acid 6% Foam 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 advers reactions in nursing infants from the mother’s use of Salicylic Acid 6% Foam, 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 the potential carcinogenic or reproductive effects of Salicylic Acid 6% Foam. It has been
    shown to lack mutagenic potential in the Ames Salmonella test.


  • GENERAL PRECAUTIONS

    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 a physician.


  • DOSAGE & 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.


  • 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.


  • 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


  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 
    salicylic acid aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-112
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTANE (UNII: 6LV4FOR43R)  
    PROPANE (UNII: T75W9911L6)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42192-112-70 70 g in 1 CANISTER; Type 0: Not a Combination Product 07/16/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/16/2010
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    Name Address ID/FEI Business Operations
    Span Packaging Services LLC 557434805 manufacture(42192-112)