Salicylic Acid Shampoo

• If you have an allergy to salicylic acid or any other part of salicylic acid shampoo.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take salicylic acid shampoo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause very bad and sometimes life-threatening allergic reactions or very bad irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use salicylic acid shampoo as you were told by the doctor or read the package label. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• Do not put on irritated skin.
• Do not use salicylic acid shampoo on birthmarks, moles, or warts with hair growth; or cervical, genital, or oral warts.
• If you use this medicine too often, your skin problem may become worse.
• Use of other skin products while using salicylic acid shampoo may cause more irritation.
• Talk with your doctor before you use other drugs or products on your skin.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
• Use with care in children. Talk with the doctor.
• Do not give to a child younger than 2 years of age.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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:

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) 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.

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.

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.

For external use only. Avoid contact with eyes and other mucous
membranes.

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.

 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.

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.

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.

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

See Warnings.

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.

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

NDC 42546-279-06

Rx Only

Salicylic Acid Shampoo 6% (w/w)

177mL

PruGen, Inc. Pharmaceuticals

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 1 NDC:42546-279-06 1 BOTTLE (BOTTLE) 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)

Revised: 02/2013   PruGen, Inc.