6% Salicylic Acid Gel

SALICYLIC ACID  - salicylic acid gel 
River's Edge Pharmaceuticals, LLC

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6% Salicylic Acid Gel

INDICATIONS AND USAGE

For the removal of excess keratin in hyperkeratotic
disorders, including scaling associated with psoriasis
or thickened skin of palms and soles, corns and
calluses.

DOSAGE AND ADMINISTRATION

Apply 6% Salicylic Acid Gel thoroughly to the affected
area and cover the area at night. The skin should be
soaked in water for at least five minutes prior to
application, preferably. The medication is washed off in
the morning. In those areas where occlusion is difficult
or impossible, more frequent application may be
necessary. Once clearing is apparent, occasional use
of 6% Salicylic Acid Gel will usually help maintain the
remission. Hands should be rinsed thoroughly after
application, unless hands are being treated.

DOSAGE FORMS AND STRENGTHS

6% Salicylic Acid Gel

CONTRAINDICATIONS

6% Salicylic Acid Gel should not be used in any
patient known to be sensitive to salicylic acid or any
other listed ingredient. 6% Salicylic Acid Gel should
not be used in children under 2 years of age.

WARNINGS AND PRECAUTIONS

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 6%
Salicylic Acid Gel should be discontinued. Fluids
should be administered to promote urinary excretion.
Treatment with sodium bicarbonate (oral or
intravenous) should be instituted as appropriate.
Considering the potential risk of developing Reye’s
Syndrome, salicylate products should not be
administered to children or teenagers with varicella or
influenza, unless directed by a physician.

For external use only. Avoid contact with eyes and
other mucous membranes. Mild burning or stinging
may occur. 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 your physician.
Flammable. Keep away from heat and open flame.
Keep this and all medications out of reach of children.

ADVERSE REACTIONS

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

Call your doctor for medical advice about side
effects. You may report side effects to the FDA at
1-800-FDA-1088.

DRUG INTERACTIONS

Salicylates compete with the binding of several drugs
and can modify the action of these drugs. Due to the
competition of salicylate with other drugs for binding to
serum albumin, the following drug interactions may
occur:
Tolbutamide, Sulfonylureas—Can potentiate
hypoglycemia.
Methotrexate—Decreases tubular reabsorption.
Oral Anticoagulants—Increases bleeding.
Corticosteroids—Decreases plasma salicylate level;
Tapering doses of steroids may promote salicylism.
Ammonium Sulfate—Increases plasma salicylate level.
Heparin Salicylate—Decreases platelet adhesiveness
and interferes with hemostasis in heparin-treated
patients.
Pyrazinamide—Inhibits pyrazinamide-induced
hyperuricemia.
Uricosuric Agents—Effect of probenecid,
sulfinpyrazone and phenylbutazone inhibited.

USE IN SPECIFIC POPULATIONS

Pregnancy
There are no adequate and well-controlled studies in
pregnant women. 6% Salicylic Acid Gel should be
used during pregnancy only if the potential benefit
justifies the risk to the fetus.

Nursing Mothers
Because of the potential for serious adverse reactions
in nursing infants from the mother’s use of 6%
Salicylic Acid Gel, 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.

OVERDOSAGE

In cases of suspected salicylate toxicity, the use of 6%
Salicylic Acid Gel should be discontinued, and the
patient should be monitored closely for signs of:
nausea, vomiting, dizziness, loss of hearing, tinnitus,
lethargy, hyperpnoea, diarrhea, psychic disturbances.
Call your local poison control center and/or your doctor
if overdosage is suspected.

DESCRIPTION

6% Salicylic Acid Gel is a gel for topical
administration containing 6% Salicylic Acid in a vehicle
composed of Disodium EDTA, Hydroxyethyl Cellulose,
Propylene Glycol, Purified Water, SD Alcohol 40-2.

CLINICAL PHARMACOLOGY

Salicylic acid is a keratolytic that has been shown to
produce desquamation of the stratum corneum of the
skin while not effecting qualitative or quantitative
changes in the structure of the viable epidermis. The
exact mechanism of action is unknown, however, it has
been attributed to the dissolution of intercellular
adhesions . While topical administration can lead to
systemic absorption, systemic toxic reactions are
usually associated with much higher serum
concentrations (30 to 40 mg/100 ml). Occlusion can
lead to higher systemic absorption.

Almost 95% of a single dose of salicylate is excreted
within 24 hours of its entrance into the extracellular
space. 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. (See PRECAUTIONS.)

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY

No data is available concerning potential carcinogenic
or reproductive effects of 6% Salicylic Acid Gel. It has
been shown to lack mutagenic potential in the Ames
Salmonella test.

HOW SUPPLIED

40 g tube of translucent gel, NDC 68032-227-41

Store at controlled room temperature 15° to 30°C (59°
to 86°F).

Rx Only

PACKAGING

NDC 68032-227-41

6% Salicylic Acid Gel

Rx Only

Net Wt 40 g

INGREDIENTS: Active Ingredient: Salicylic Acid 6.0%. Inactive
Ingredients: Disodium EDTA, Hydroxyethyl Cellulose, Propylene Glycol,
Purified Water, SD Alcohol 40-2.

INDICATIONS: For the removal of excess keratin in hyperkeratotic
disorders, including scaling associated with psoriasis or thickened skin
of the palms and soles, corns and calluses.

DIRECTIONS: Apply 6% Salicylic Acid Gel thoroughly to the affected
area and cover the area at night. The skin should be soaked in water for
at least five minutes prior to application, preferably. The medication is
washed off in the morning. In those areas where occlusion is difficult or
impossible, more frequent application may be necessary. Once clearing
is apparent, occasional use of 6% Salicylic Acid Gel will usually help
maintain the remission. Hands should be rinsed thoroughly after
application, unless hands are being treated.

WARNINGS: For external use only. Avoid contact with eyes and other
mucous membranes. May cause mild irritation. If excessive irritation or
sensitivity occurs, discontinue use and consult your physician. Do not
use on children under 2 years of age. Read package insert carefully.
Flammable. Keep away from heat and open flame. Keep this and all
medications out of reach of children.

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Rev. 01/09 227-22

Manufactured for:

River's Edge Pharmaceuticals, LLC

Suwanee, GA 30024

6% SALICYLIC ACID GEL PACKAGING1


SALICYLIC ACID 
6% salicylic acid   gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-227
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid6   in 40 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-227-4140 g In 1 POUCHNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other05/27/2007

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 10/2009River's Edge Pharmaceuticals, LLC