Salicate
Generic: SALICYLIC ACID 10%
Basic Information
Manufacturer
PureTek Coproration
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
fd699cfb-8c9f-ebb8-e053-6394a90ace4a
Indications & Usage
Indications & Usage: For dermatologic Use Salicate™ is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis.
For Podiatric Use Salicate™ is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.
For Podiatric Use Salicate™ is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.
Warnings
Warnings: Salicate™ is for external use only.
It is not for ophthalmic, oral, anal, or intravaginal use.
Contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided.
Salicate™ should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients.
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 should be 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, Salicate™ 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.
When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
If irritation occurs, only use one topical acne medication at a time.
Applying the serum more than once per week will increase the risk of skin sensitivity.
It is not for ophthalmic, oral, anal, or intravaginal use.
Contact with eyes, lips, broken or inflamed skin, and mucous membranes should be avoided.
Salicate™ should not be used by persons who have a known hypersensitivity to salicylic acid or other listed ingredients.
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 should be 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, Salicate™ 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.
When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
If irritation occurs, only use one topical acne medication at a time.
Applying the serum more than once per week will increase the risk of skin sensitivity.
Adverse Reactions
Adverse Reactions: Transient stinging, burning, itching or irritation is possible.
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.
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.