Label: SALICYLIC ACID 6 PERCENT- salicylic acid shampoo

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/13

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  • DESCRIPTION

    Salicylic Acid Shampoo contains 6% w/w salicylic acid USP in a
    vehicle consisting of purified water, acrylates copolymer, sodium
    laureth sulfate, trolamine, quaternium 26 and propylene glycol,
    cocamidopropyl betaine, behentrimonium methosulfate and
    cetearyl alcohol, propylparaben, methylparaben, glycerin, disodium
    EDTA and chamomile tea fragrance.
    Salicylic acid is the 2-hydroxy derivative of benzoic acid having
    the following structure:

    salacid

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  • CLINICAL PHARMACOLOGY

    Salicylic acid has been shown to produce desquamation of the
    horny layer of skin while not effecting qualitative or quantitative
    changes in the structure of the viable epidermis. The mechanism
    of action has been attributed to a dissolution of intercellular
    cement substance.
    In a study of the percutaneous absorption of salicylic acid in a 6%
    salicylic acid gel in four patients with extensive active psoriasis,
    Taylor and Halprin showed that the 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/100ml).
    Peak serum levels occurred within five hours of the topical appli-
    cation under occlusion. The sites were occluded for 10 hours over
    the entire body surface below the neck. Since salicylates are dis-
    tributed in the extracellular space, patients with a contracted
    extracellular space due to dehydration or diuretics have a higher
    salicylate levels than those with a normal extracellular space. (See
    PRECAUTIONS)
    The major metabolites identified in the urine after topical admin-
    istration are salicyluric acid (52%), salicylate glucuronides (42%)
    and free salicylic acid (6%). The urinary metabolites after percu-
    taneous absorption differ from those after oral salicylate adminis-
    tration; those derived from percutaneous absorption contain
    more salicylate 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 a salicylate is protein bound to albumin.
    Salicylates compete with the binding of several drugs and can
    modify the actions of these drugs; by similar competitive mech-
    anisms other drugs can influence the serum levels of salicylate.
    (See PRECAUTIONS) Close
  • INDICATIONS & USAGE

    For Dermatologic Use: Salicylic Acid 6% (w/w) Shampoo is a top-
    ical aid in the removal of excessive keratin in hyperkeratotic skin
    disorders, including verrucae, and the various ichthyoses (vul-
    garis, sex-linked and lamellar), keratosis palmaris and plantaris,
    keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including
    body, scalp, palms and soles).
    For Podiatric Use: Salicylic Acid 6% (w/w) Shampoo is a topical
    aid in the removal of excessive keratin on the dorsal and plantar
    hyperkeratotic lesions. Topical preparations of 6% salicylic acid
    have been reported to be useful adjunctive therapy for verrucae
    plantares. Close
  • CONTRAINDICATIONS

    Salicylic Acid 6% (w/w) Shampoo should not be used in any
    Patient known to be sensitive to salicylic acid or any other listed
    ingredients. Salicylic Acid 6% (w/w) Shampoo should not be
    used in children under 2 years of age.

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  • WARNINGS

    Prolonged use over large areas, especially in children and those
    patients with significant renal or hepatic impairment could result
    in salicylism. Excessive application of the product other than is
    needed to cover the affected area will not result in more therapeutic
    benefit. 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, hyperpnea, diarrhea, and psychic dis-
    turbances. In the event of salicylic acid toxicity, the use of the
    Salicylic Acid 6% (w/w) Shampoo should be discontinued. Fluids
    should be administered  to promote urinary excretion. Treatment
    with sodium bicarbonate (oral or intravenous) should be instituted
    as appropriate. Patients should be cautioned against the use of
    oral aspirin and other salicylate containing medications, such as
    sports and injury creams, to avoid additional excessive exposure
    to salicylic acid. Where needed, aspirin should be replaced by an
    alternative non-steroidal, anti-inflammatory agent that is not sali-
    cylate based.
    Due to potential risk of developing Reye’s syndrome, salicylate
    products should not be used in children and teenagers with vari-
    cella or influenza, unless directed by a physician.


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  • PRECAUTIONS

    For external use only. Avoid contact with eyes and other mucous
    membranes. Close
  • DRUG INTERACTIONS

    The following interactions are from a published review and
    include reports concerning both oral and topical salicylate admin-
    istration. The relationship of these interactions to the use of
    Salicylic Acid 6% (w/w) Shampoo is not known.
    I.Due to the competition of salicylate with other drugs for
    bindingto serum albumin the following drug interactions may
    occur:
    DRUGDESCRIPTION OF INTERACTION
    SulfonylureasHypoglycemia potentiated.
    MethotrexateDecreases tubular reabsorption; clinical
    toxicity from methotrexate can result.
    OralIncreased bleeding.
    Anticoagulants
    II.Drugs changing salicylate levels by altering renal tubular
    reabsorption:
    DRUGDESCRIPTION OF INTERACTION
    CorticosteroidsDecreases plasma salicylate level; tapering
    doses of steroids may promote salicylism.
    AcidifyingIncreases plasma salicylate level.
    Agents
    AlkanizingDecreased plasma salicylate levels.
    Agents
    III.Drugs with complicated interactions with salicylates:
    DRUGDESCRIPTION OF INTERACTION
    HeparinSalicylate decreases platelet adhesiveness
    and interferes with hemostasis in heparin
    treated patients.
    Pyrazinamide
    Inhibits pyrazinamide-induced
    uricemia.
    hyper-
    UricosuricEffect of probenemide, sulfinpyrazone and
    phenylbutazone inhibited.
    The following alterations of laboratory tests have been reported
    during salicylate therapy:
    LABORATORYEFFECT OF SALICYLATES
    TESTS
    ThyroidDecreased PBI; increased Tuptake.
    3
    Function
    Urinary SugarFalse negative with glucose oxidase; false
    positive with Clinitest with high-dose sali-
    cylate therapy (2-5g q.d.).
    5- HydroxyindoleFalse negative with fluorometric test.
    acetic acid
    Acetone,False positive FeClin Gerhardt reaction;
    3
    ketone bodiesred color persists with boiling.
    17-OHFalse reduced values with >4.8g
    corticosteroidsq.d. salicylate.
    VanilmandelicFalse reduced values.
    acid09-0080
    Uric acidMay increase or decrease depending on
    dose.
    ProthrombinDecreased levels; slightly Increased pro-
    thrombin time.

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  • PREGNANCY

     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 six
    times the maximal 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. Salicylic Acid 6%
    (w/w) Shampoo should be used during pregnancy only if the
    potential benefit justifies the potential risk to the fetus. Close
  • NURSING MOTHERS

    Because of the potential for serious adverse
    reactions in nursing infants from the mother’s use of Salicylic
    Acid 6% (w/w) Shampoo, 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. If used by
    nursing mothers, it should not be used on the chest area to avoid
    the accidental contamination of the child.

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  • CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

    No data are available concerning potential carcinogenic or reproductive
    effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has
    been shown to lack mutagenic potential in the Ames Salmonella
    test.

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  • ADVERSE REACTIONS

    Excessive erythema and scaling conceivably could result from
    use on open skin lesions.

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  • OVERDOSAGE

    See Warnings.

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  • DOSAGE & ADMINISTRATION

    Wet hair and apply Salicylic Acid 6% (w/w) Shampoo to the scalp.
    Work into a lather then rinse. Repeat the treatment as needed until
    the condition clears. Once clearing is apparent, the occasionaluse
    of Salicylic Acid 6% (w/w) Shampoo will usually maintain the
    remission. Close
  • HOW SUPPLIED

    Salicylic Acid 6% (w/w) Shampoo is available in 177mL plastic
    bottles (NDC 42546-279-06).
    Store at controlled room temperature 20°-25°C (68°-77°F). Do
    not freeze

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  • PRINCIPAL DISPLAY PANEL

    NDC 42546-279-06

    Rx Only

    Salicylic Acid Shampoo 6% (w/w)

    177mL

    PruGen, Inc. Pharmaceuticals

    front label

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  • INGREDIENTS AND APPEARANCE
    SALICYLIC ACID 6 PERCENT 
    salicylic acid shampoo
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42546-279
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    salicylic acid (salicylic acid) salicylic acid 6 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    CARBOMER COPOLYMER TYPE A  
    SODIUM LAURETH SULFATE  
    TROLAMINE  
    QUATERNIUM-22  
    COCAMIDOPROPYL BETAINE  
    BEHENTRIMONIUM METHOSULFATE  
    PROPYLPARABEN  
    METHYLPARABEN  
    GLYCERIN  
    EDETATE DISODIUM  
    CHAMOMILE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42546-279-06 1 in 1 BOX
    1 177 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2009
    Labeler - PruGen, Inc. (929922750)
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