Salicylic Acid 6 Percent

Salicylic Acid 6 Percent

Salicylic Acid 6 Percent Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.


Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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

Salicylic Acid 6 Percent Manufacturers


  • Prugen, Inc.
    Salicylic Acid 6 Percent (Salicylic Acid) Shampoo [Prugen, Inc.]

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