Urea cream
Pronunciation: yoo-REE-uh.
- Generic name
- urea (carbamide) cream
- Drug class
- Topical keratolytic / emollient
- Form
- Cream (concentrations commonly 10%, 20%, 22%, 25%, 40%, 45% combined with 2% salicylic acid, or 48%, depending on brand and intended use)
- Route
- Topical (skin and nails only)
- Legal status
- Over-the-counter (OTC) / General Sales List in every market confirmed this session (United States, United Kingdom, Australia, Canada, New Zealand); always check your specific product's own label and country.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Aquacare/HP (4) · Full directory
What urea (carbamide) cream is and how it works
Urea cream is a topical keratolytic emollient. Urea softens and loosens keratin, the tough protein that makes up the outer layer of skin and nails, helping remove excess dead skin and improve moisture retention. Lower-strength versions (about 10-25% urea) are used as everyday moisturisers for dry or rough skin; higher-strength versions (typically 40% or more, sometimes combined with 2% salicylic acid) are used as keratolytic debriding agents to soften and remove thickened, hardened skin or nail tissue. (1) (6)
In the United States, current OTC drug-facts labelling for plain urea cream products carries the standard OTC-monograph disclaimer that the product 'has not been found by FDA to be safe and effective, and this labelling has not been approved by FDA' -- a real regulatory nuance for many long-standing OTC monograph-category topical products, not a sign the product is unsafe, but something worth knowing honestly rather than assuming it means full individual FDA approval.
Mechanism of action: how urea (carbamide) cream works
Urea is a naturally occurring compound with humectant (moisture-binding) and keratolytic properties. At lower concentrations it draws and holds water in the outer skin layer (stratum corneum), improving hydration and softness. At higher concentrations it disrupts hydrogen bonding within keratin, loosening and helping remove excess or thickened dead skin and softening hardened nail tissue. (1)
What urea (carbamide) cream is used for
Dry, rough, or itchy skin (everyday moisturising use)
Lower-strength urea creams (about 10-25%) are used to moisturise, soften, and smooth dry or rough skin, including in conditions such as atopic eczema, xerosis, and ichthyosis. (4) (6)
Hyperkeratotic (thickened) skin conditions
Used for dermatitis, psoriasis, keratosis pilaris, corns, and calluses where excess or thickened skin needs softening. (1)
Damaged, thickened, or ingrown nails (higher-strength keratolytic use)
Higher-strength urea creams (commonly 40% and above) are used as a keratolytic agent to soften thickened tissue in damaged, ingrown, or devitalised nails ahead of debridement or removal, typically as directed by a clinician. (1) (5)
Before taking urea (carbamide) cream
Do not take / not appropriate for
- Do not use on broken, weeping, infected, or oozing skin. (all countries) (6)
- Not for ophthalmic use -- avoid contact with the eyes, lips, or other mucous membranes. (all countries) (1)
- Do not use if you have a known sensitivity or allergic reaction to urea or any other ingredient in your specific product. (all countries) (5)
Tell your clinician about
- Any known skin allergies or sensitivities, or a past reaction to a urea-containing product.
- Whether you have diabetes or poor circulation, particularly before using a higher-strength keratolytic product on the feet or nails, since skin/nail debridement carries added risk in these situations.
- Whether the area you plan to treat is broken, infected, or weeping -- these should not be self-treated with urea cream.
- Any other topical medicines or products you are using on the same area.
How to take urea (carbamide) cream
- For external use only -- apply to the skin or nails as directed, rubbing in until completely absorbed.
- Do not apply to broken, infected, or weeping skin.
- Apply liberally shortly after bathing, while the skin is still slightly damp, if using as an everyday moisturiser.
- For higher-strength keratolytic products used on thickened skin or nails, follow your clinician's or the product label's specific directions, since strength and intended use vary widely by product.
- If you use a paraffin-containing urea cream, be aware that paraffin-soaked clothing or dressings can be a fire hazard near naked flames or smoking materials -- keep away from open flame.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)
Missed dose
If you miss an application, simply apply it at your next scheduled time and continue your regular routine -- there is no need to apply extra cream to make up for it. Contact your pharmacist or clinician if you are unsure how to get back on schedule.
Overdose
Urea cream is for external use only. If accidentally swallowed, or if a large amount is applied and causes marked skin irritation, contact a poison control centre or seek medical attention. Seek prompt medical review if it comes into contact with the eyes or other mucous membranes and irritation does not settle after rinsing with water. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Transient stinging, burning, itching, or irritation at the application site, which normally settles after stopping use.
What to notice: Transient stinging, burning, itching, or irritation at the application site, which normally settles after stopping use.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Redness or a rash that can be mistaken for an eczema flare.
What to notice: Redness or a rash that can be mistaken for an eczema flare.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (6)
Serious warnings
Signs of a sensitivity or allergic skin reaction — high caution
Symptoms: Worsening redness, stinging, itching, or a rash spreading beyond the treated area, which can be mistaken for an eczema flare.
Action: Stop using the product and contact your pharmacist or clinician for advice if a reaction develops or does not settle. (6)
Accidental contact with eyes or mucous membranes — high caution
Symptoms: Eye stinging, redness, or irritation after accidental contact.
Action: Rinse thoroughly with water and seek medical review if irritation persists -- this product is not for ophthalmic use. (1)
Fire hazard with paraffin-containing formulations — important safety information
Symptoms: Not applicable -- this is a product-handling hazard rather than a body symptom.
Action: Paraffin-containing emollient creams can soak into clothing, dressings, and bedding, and are a real fire hazard near naked flames, cigarettes, or other smoking materials; keep well away from open flame and sources of ignition. (6)
Interactions
- No clinically significant drug-drug interactions are described for topical urea cream in the sources reviewed for this dossier -- it is not absorbed in a way that is expected to interact with oral or injected medicines when used as directed on intact skin. (1)
- Using urea cream at the same time as other topical products on the same area (for example other keratolytics or medicated creams) may increase local irritation -- space out or check with a pharmacist before combining products on the same skin area. (6)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
No specific pregnancy restriction is described for topical urea cream in the sources reviewed for this dossier; as with any topical product, discuss use with a clinician or pharmacist if pregnant, particularly for higher-strength keratolytic products. (1) (2) (3) (4) (5) (6) (7)
Breastfeeding
No specific breastfeeding restriction is described in the sources reviewed for this dossier; avoid applying to the nipple/areola area, or consult a clinician or pharmacist if this is needed. (1) (2) (3) (4) (5) (6) (7)
Children
Everyday-strength moisturiser products are widely marketed for general dry-skin use; higher-strength keratolytic products are typically directed by a clinician, and paediatric use should follow the specific product's own label or a clinician's direction. (1) (2) (3) (4) (5) (6) (7)
Elderly
No specific dose adjustment based on age alone is described in the sources reviewed; older adults with diabetes or poor circulation should have higher-strength keratolytic use on the feet or nails directed by a clinician. (1) (2) (3) (4) (5) (6) (7)
Hepatic_impairment
No specific restriction described for topical use in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Renal_impairment
No specific restriction described for topical use in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Source_ids
US-DAILYMED-UREA-CREAM-40-LABEL-2026,NZ-HEALTHIFY-UREA-CREAM-2026 (1) (2) (3) (4) (5) (6) (7)
Monitoring
Before starting
- Check that the area to be treated is intact -- not broken, infected, or weeping.
- Check your specific product's concentration and intended use (everyday moisturiser vs. keratolytic debriding agent).
During treatment
- If worsening irritation, stinging, or a spreading rash develops, stop using the product and follow up with your clinician or pharmacist.
- For higher-strength keratolytic use directed by a clinician (for example on thickened nails), follow up as directed to check on progress and skin condition.
Storage
Store at room temperature (about 15-30C / 59-86F); protect from freezing. Keep out of reach of children.
Professional information
Clinician-facing context only, sourced from the current US DailyMed OTC drug-facts label plus UK EMC, Australia TGA, Canada Health Canada LNHPD, and New Zealand Healthify sources reviewed for this dossier; verify against the current full label for the specific product before recommending.
United States, Canada
Indication: Higher-strength keratolytic use (commonly 40% urea, sometimes with 2% salicylic acid)
Dose summary: Apply to affected skin twice daily, or as a physician directs, rubbed in until completely absorbed; apply to damaged nails twice daily or as a physician directs.
Renal context: Not applicable -- topical use only, no renal dosing adjustment described in the sources reviewed. (1) (5)
United Kingdom, Australia, New Zealand
Indication: Everyday moisturiser/emollient use (commonly 10-25% urea)
Dose summary: Apply 2-3 times daily or as directed on the specific product's label, ideally shortly after bathing while skin is still damp.
Renal context: Not applicable -- topical use only, no renal dosing adjustment described in the sources reviewed. (6) (4) (3)
Hepatic guidance
No specific hepatic caution described for topical use in the sources reviewed for this dossier.
Overdose note
No specific antidote required for topical use; manage marked local irritation supportively and treat accidental ingestion or eye contact as a general poisoning/irritant exposure per local poison-control guidance. (1)
Frequently asked questions
Is urea cream available in the US, UK, Australia, Canada, and New Zealand?
Yes, confirmed directly via each country's own regulator or government health source this session: the United States (DailyMed OTC drug-facts labels), United Kingdom (EMC-licensed General Sales List products such as Balneum Plus Cream and E45 Itch Relief Cream), Australia (TGA-registered Aquacare/HP), Canada (Health Canada-licensed Urisec 40), and New Zealand (Healthify-listed AquaCare HP and Eulactol). A direct European Union regulator search could not be completed this session (a technical failure), so EU-wide medicine-regulator authorisation beyond the UK is not claimed here. (1) (3) (4) (5) (6) (7)
What is the difference between a 10% and a 40% urea cream?
Lower-strength urea creams (roughly 10-25%) are typically marketed as everyday moisturisers for dry or rough skin. Higher-strength urea creams (commonly 40% and above, sometimes combined with 2% salicylic acid) are marketed specifically as keratolytic debriding agents to soften and remove thickened, hardened skin or nail tissue, and are often used under a clinician's direction, particularly for nail conditions. (1) (6)
Has the FDA approved urea cream?
Plain urea cream products in the United States are regulated under the FDA's OTC drug-monograph framework rather than through an individual new-drug approval. The current DailyMed drug-facts label for one such product states verbatim: 'This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.' This is standard language for many long-standing OTC monograph-category topical products and does not by itself mean the product is unsafe. (1)
Can I use urea cream on broken or infected skin?
No. Urea cream should not be applied to broken, infected, weeping, or oozing skin. Speak to a clinician or pharmacist about a suitable alternative if the area you want to treat is broken or shows signs of infection. (6)
What is the mechanism of action of urea (carbamide) cream?
Urea is a naturally occurring compound with humectant (moisture-binding) and keratolytic properties. At lower concentrations it draws and holds water in the outer skin layer (stratum corneum), improving hydration and softness. At higher concentrations it disrupts hydrogen bonding within keratin, loosening and helping remove excess or thickened dead skin and softening hardened nail tissue. (1)
References
- Urea Cream 40% -- Drug Facts labelDailyMed (U.S. National Library of Medicine) -- OTC drug facts label · United States · accessed 2026-07-30 · source 1
- DailyMed search for 'urea cream' -- 50 products found across concentrationsDailyMed (U.S. National Library of Medicine) -- product label search · United States · accessed 2026-07-30 · source 2
- emc.medicines.org.uk search for 'urea cream' -- Balneum Plus Cream, Cymex Cream, E45 Itch Relief Creamelectronic medicines compendium (emc), United Kingdom -- product search · United Kingdom · accessed 2026-07-30 · source 3
- Aquacare/HP Urea 100mg/g Cream (ARTG 23199)Therapeutic Goods Administration (TGA), Australia -- ARTG entry · Australia · accessed 2026-07-30 · source 4
- URISEC 40 (40% Urea) -- Product Licence Information (Licence 80005531)Health Canada -- Licensed Natural Health Products Database (LNHPD) · Canada · accessed 2026-07-30 · source 5
- Urea cream -- Healthify medicines A-ZHealthify (Te Whatu Ora / Health New Zealand-funded national health information service) · New Zealand · accessed 2026-07-30 · source 6
- EMA medicine search for 'urea cream' -- technical failure (HTTP 401)n/a -- disclosed live-query technical failure, not a confirmed negative or positive result · European Union · accessed 2026-07-30 · source 7
Brand names by country
Single-ingredient urea (carbamide) cream names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Urevia400 mg/g, 390 mg/g · blue heron pharmaceuticals, llc
- UREDEX200 mg/g · blue heron pharmaceuticals, llc
- Uracin 20%.2 g/g · puretek corporation
- iShanCare Cracked Skin Cream15 g00g · shenzhen ishan technology co., ltd
- AVENASTER FUNGAL NAIL CARE DUO SET (DAY)20 g00mL · jiangxi yudexi pharmaceutical co., ltd
- Evara405 mg/g · oncora pharma, llc
- DERMACURE410 mg/g · oncora pharma, llc
- MILKBODyLotion100 mg/mL · shengnan (guangzhou) cosmetics co., ltd
- UREVEX200 mg/g · blue heron pharmaceuticals, llc
United Kingdom
Canada
- Urisec 40 (5)Health Canada LNHPD active licence confirmed · 40% · Odan Laboratories Ltd.
Australia
- Aquacare/HP (4)TGA ARTG registered 1991-10-14 confirmed · 10% (100mg/g) · AbbVie Pty Ltd