Urea 39.5% with 2% Salicylic Acid
39.5 g/100g + 2 g/100g · Cream
- Prescription only
- Active substance
- Urea, Salicylic Acid
- Made by
- PureTek Corporation
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-03-24
- For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar.
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar.
- Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
From the official label · 2023-03-24 · DailyMed
How it works
From this product’s own US prescribing label.
Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.
The mechanism of action of topically applied urea is not yet known.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-03-24
Do not take it if
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
Apply Urea 39.5% Cream with 2% Salicylic Acid to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- FOR EXTERNAL USE ONLY.
- NOT FOR OPHTHALMIC USE.
- KEEP OUT OF REACH OF CHILDREN.
- Avoid contact with eyes, lips and mucous membranes.When using this product skin irritation and dryness is more likely to occur.
- General This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed.
- If redness or irritation occurs, discontinue use and consult a physician.
- Information for Patients Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere.
- Carcinogenesis, Mutagenesis and Impairment of Fertility:
- Long-term animal studies for carcinogenic potential have not been performed on this product to date.
- Studies on reproduction and fertility also have not been performed.
- Pregnancy: Category C .
- Nursing Mothers: It is not known whether this drug is excreted in human milk.
- General This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Category C .
- Animal reproduction studies have not been conducted with this product.
- It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman.
- This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Side effects
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere.
- Avoid contact with eyes, lips and mucous membranes.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
Urea 39.5% Cream with 2% Salicylic Acid 8 oz. (227 g): NDC 59088-210-16
Quoted from the official label, section “How Supplied”.
What is in it
- Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space.
- Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of:
- Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid.
- Urea is a diamide of carbonic acid with the following chemical structure:
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Details
| Made by | PureTek Corporation |
|---|---|
| Active substance | Urea, Salicylic Acid |
| Strength | 39.5 g/100g + 2 g/100g |
| Form | Cream |
| Route | Topical |
| Packs | 227 g in 1 JAR |
| NDC | 59088-210 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).