Drugplain

Salicylic Acid 6% Gel 6 g/100mL

SALICYLIC ACID · GEL · PureTek Corporation

No Recall History
Plain English

Salicylic Acid 6% Gel is a gel containing salicylic acid at 6 g/100mL, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Salicylic Acid 6% Gel
Generic Name
SALICYLIC ACID
NDC Code (Product)
59088-261
Manufacturer
PureTek Corporation
Strength
6 g/100mL
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Marketing Start
02/19/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vomiting199 reports
pruritus196 reports
condition aggravated182 reports
headache180 reports
weight decreased173 reports
drug ineffective172 reports
infection172 reports
hypertension171 reports
urticaria168 reports
weight increased167 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE For Dermatologic Use: Salicylic Acid 6% Gel is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders including verrucae, and the various ichthyoses (vulgaris, 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% Gel is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions.

Dosage & Administration

DOSAGE AND ADMINISTRATION The preferable method of use is to apply Salicylic Acid 6% Gel thoroughly to the affected area and to cover the treated area at night after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning, and if excessive drying and/or irritation is observed, a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of Salicylic Acid 6% Gel will usually maintain the remission. In those areas where occlusion is difficult or impossible, application may be made more frequently, hydration by wet packs or baths prior to application apparently enhances the effect (See WARNINGS ). Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of Salicylic Acid 6% Gel will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

Warnings

WARNINGS 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 under12 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 disturbances. In the event of salicylic acid toxicity, the use of Salicylic Acid 6% Gel 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 injury creams, to avoid additional excessive exposure to salicylic acid. When needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based. Patients shou…

Contraindications

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

Drug Interactions

DRUG INTERACTIONS (The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salicylic Acid 6% Gel is not known). I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: II. Drugs changing salicylate levels by altering renal tubular reabsorption: III. Drugs with complicated interactions with salicylates: The following alterations of laboratory tests have been reported during salicylate therapy: Pregnancy: (Category C) - 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 4 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% Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers : Because of the potential…

Adverse Reactions

ADVERSE REACTIONS Excessive erythema and scaling conceivably could result from use on open skin lesions. Call your licensed healthcare practitioner for medical advice about side effects.

Frequently Asked Questions

What is Salicylic Acid 6% Gel used for?

Salicylic Acid 6% Gel contains SALICYLIC ACID. It is a gel taken topical. Consult your doctor for specific uses.

Is Salicylic Acid 6% Gel a controlled substance?

Salicylic Acid 6% Gel is not classified as a controlled substance by the DEA.

What is the generic name for Salicylic Acid 6% Gel?

The generic name for Salicylic Acid 6% Gel is SALICYLIC ACID. There are 12 other brand versions of SALICYLIC ACID.

What is the NDC code for Salicylic Acid 6% Gel 6 g/100mL?

The NDC (National Drug Code) for Salicylic Acid 6% Gel 6 g/100mL is 59088-261, listed by PureTek Corporation.

Product NDC

59088-261

Package NDC

59088-261-03

Other Salicylic Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)