Urea 41% Cream 227gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Humectant
Pharmacologic Class
Keratolytic; Humectant
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is a medication used to treat very dry, rough, or scaly skin conditions like calluses, corns, psoriasis, or eczema. It works by helping your skin shed dead cells and by drawing moisture into the skin, making it softer and smoother.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Only apply the medication to the affected area.
If desired, you can cover the treated area with a bandage or dressing.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
* Keep the lid tightly closed.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Apply this medication only to your skin. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Only apply the medication to the affected area.
If desired, you can cover the treated area with a bandage or dressing.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
* Keep the lid tightly closed.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or take extra doses.
Lifestyle & Tips
- Apply to clean, dry skin.
- Wash hands before and after application.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds or broken skin unless directed by a healthcare professional.
- For best results, apply regularly as directed.
- Consider wearing cotton gloves or socks after application to enhance absorption and protect clothing.
Available Forms & Alternatives
Available Strengths:
- Urea Hydrating 35% Foam
- Urea 45% Cream 255gm
- Urea Nail 45% Gel 28ml
- Urea 39% Cream 226.8gm
- Urea 20% Cream 85gm
- Urea 40% Cream 28.35gm
- Urea 40% Cream 85gm
- Urea 40% Cream 198.4gm
- Urea 41% Cream 227gm
- Urea 47% Cream 142gm
- Urea 40% Lotion 226.8gm
- Urea 39% Cream 227gm
- Urea 10% Hydrating Cream 85gm
- Urea 10% Lotion 177ml
- Urea 10% Lotion 240ml
- Urea 10% Cream 85gm
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply a thin layer to the affected area and rub in thoroughly. May be covered with an occlusive dressing if desired.
Pediatric Dosing
Neonatal:
Not established (use with caution, especially on large surface areas due to potential for increased systemic absorption)
Infant:
Not established (use with caution, especially on large surface areas due to potential for increased systemic absorption)
Child:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician. Use with caution on large surface areas.
Adolescent:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Dialysis:
No adjustment needed for topical use.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that promotes softening and dissolution of the horny layer of skin. It also has humectant properties, increasing the water content of the stratum corneum, thereby hydrating the skin. At high concentrations (e.g., 41%), it can also have a mild anesthetic effect and promote debridement of necrotic tissue.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption following topical application to intact skin.
Tmax:
Not clinically significant for topical application.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not clinically significant for topical application (primarily local action).
ProteinBinding:
Not clinically significant for topical application.
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically significant for topical application.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily local action; minimal systemic excretion.
Unchanged:
Not clinically significant for topical application.
Pharmacodynamics
OnsetOfAction:
Within days to weeks for full keratolytic and hydrating effects.
PeakEffect:
Varies with severity of condition and duration of use.
DurationOfAction:
Dependent on continued application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation at the application site.
- Rash, itching, or swelling (signs of an allergic reaction).
- Signs of skin infection (e.g., pus, increased redness, warmth, fever) if skin is broken.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of use, as directed by your doctor, and do not exceed it.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
To ensure safe use, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Using this medication too frequently can exacerbate your skin condition.
Before using any other medications or products on your skin, including soaps, consult with your doctor to discuss potential interactions. If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
To ensure safe use, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Using this medication too frequently can exacerbate your skin condition.
Before using any other medications or products on your skin, including soaps, consult with your doctor to discuss potential interactions. If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive local irritation (severe burning, stinging, redness, peeling).
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
What to Do:
If excessive local irritation occurs, wash the area thoroughly with water and discontinue use. If symptoms persist or worsen, seek medical attention. In case of accidental ingestion, contact a poison control center immediately (Call 1-800-222-1222).
Drug Interactions
Minor Interactions
- Other topical preparations (may alter absorption or cause irritation if applied concurrently)
Monitoring
Baseline Monitoring
Skin condition (e.g., dryness, scaling, calluses)
Rationale: To assess the severity of the condition and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, burning, stinging)
Frequency: Daily, or as symptoms arise.
Target: Absence of significant irritation.
Action Threshold: Discontinue use if severe irritation occurs; consult physician.
Improvement in skin texture/appearance
Frequency: Weekly to monthly, or as clinically indicated.
Target: Softening of skin, reduction in scaling/calluses.
Action Threshold: Re-evaluate treatment if no improvement after several weeks.
Symptom Monitoring
- Skin irritation (redness, burning, stinging, itching)
- Allergic reactions (rash, swelling)
- Signs of infection if skin barrier is compromised
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy. Minimal systemic absorption is expected.
Trimester-Specific Risks:
First Trimester:
Low risk; minimal systemic absorption.
Second Trimester:
Low risk; minimal systemic absorption.
Third Trimester:
Low risk; minimal systemic absorption.
Lactation
Considered safe for use during lactation. Minimal systemic absorption by the mother is expected, and therefore minimal transfer into breast milk. Avoid applying to areas where the infant may ingest it.
Infant Risk:
Low risk.
Pediatric Use
Can be used in children, but caution is advised, especially in infants and young children, when applying to large surface areas or broken skin, due to the potential for increased systemic absorption. Consult a pediatrician for use in very young children.
Geriatric Use
No specific dose adjustments or precautions are generally necessary for geriatric patients. Use as directed for adults.
Clinical Information
Clinical Pearls
- Urea cream is highly effective for conditions characterized by thickened, dry, or scaly skin, such as hyperkeratosis, ichthyosis, psoriasis, and eczema.
- Higher concentrations (e.g., 40-50%) are primarily keratolytic, while lower concentrations (e.g., 10-20%) are more humectant/moisturizing.
- Patients should be advised that a mild stinging sensation may occur, especially on sensitive or fissured skin, but this usually subsides with continued use.
- Occlusion (covering the treated area with a dressing) can enhance the keratolytic effect, but may also increase the risk of irritation.
- Regular, consistent application is key to achieving and maintaining therapeutic effects.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Alpha hydroxy acids (topical)
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Corticosteroids (topical, for inflammatory conditions)
- Calcipotriene (topical, for psoriasis)
Cost & Coverage
Average Cost:
Variable, typically $20-$100 per 227gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.