Label: SALICYLIC ACID 6 PERCENT- salicylic acid shampoo
- NDC Code(s): 42546-279-06
- Packager: PruGen, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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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:
- 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
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
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
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
Salicylic Acid 6% (w/w) Shampoo should not be used in anyClose
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.
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-
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.
For external use only. Avoid contact with eyes and other mucous
- DRUG INTERACTIONS
The following interactions are from a published review andClose
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
DRUGDESCRIPTION OF INTERACTION
MethotrexateDecreases tubular reabsorption; clinical
toxicity from methotrexate can result.
II.Drugs changing salicylate levels by altering renal tubular
DRUGDESCRIPTION OF INTERACTION
CorticosteroidsDecreases plasma salicylate level; tapering
doses of steroids may promote salicylism.
AcidifyingIncreases plasma salicylate level.
AlkanizingDecreased plasma salicylate levels.
III.Drugs with complicated interactions with salicylates:
DRUGDESCRIPTION OF INTERACTION
HeparinSalicylate decreases platelet adhesiveness
and interferes with hemostasis in heparin
UricosuricEffect of probenemide, sulfinpyrazone and
The following alterations of laboratory tests have been reported
during salicylate therapy:
LABORATORYEFFECT OF SALICYLATES
ThyroidDecreased PBI; increased Tuptake.
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.
Acetone,False positive FeClin Gerhardt reaction;
ketone bodiesred color persists with boiling.
17-OHFalse reduced values with >4.8g
VanilmandelicFalse reduced values.
Uric acidMay increase or decrease depending on
ProthrombinDecreased levels; slightly Increased pro-
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 adverseClose
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.
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
No data are available concerning potential carcinogenic or reproductiveClose
effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has
been shown to lack mutagenic potential in the Ames Salmonella
- ADVERSE REACTIONS
Excessive erythema and scaling conceivably could result fromClose
use on open skin lesions.
- 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
- HOW SUPPLIED
Salicylic Acid 6% (w/w) Shampoo is available in 177mL plasticClose
bottles (NDC 42546-279-06).
Store at controlled room temperature 20°-25°C (68°-77°F). Do
- PRINCIPAL DISPLAY PANEL
Salicylic Acid Shampoo 6% (w/w)
PruGen, Inc. Pharmaceuticals
- 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)