Urea 40% Cream 85gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic, Emollient
Pharmacologic Class
Keratolytic agent, Humectant
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea 40% cream is a topical medication used to treat very dry, rough, or scaly skin conditions. It works by helping to soften and loosen the hard, thickened skin, making it easier to remove. It also helps your skin hold onto moisture, 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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. 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 treated area. 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 necessary, the treated area may be covered with a bandage or dressing.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. 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 treated area. 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 necessary, the treated area may be covered with a bandage or dressing.
Storage and Disposal
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply to clean, dry skin. Wash hands before and after application.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds, broken, or inflamed skin unless directed by a healthcare professional.
- For best results, apply regularly as directed.
- Wear protective clothing or gloves if applying to hands or feet to prevent accidental transfer to sensitive areas.
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 once or twice daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply to thickened skin areas, often after bathing, and rub in until absorbed.
xerosis:
Apply to dry, rough skin as needed.
Pediatric Dosing
Neonatal:
Not established (Use with caution, consult pediatrician)
Infant:
Not established (Use with caution, consult pediatrician)
Child:
Not established (Use with caution, consult pediatrician; lower concentrations may be preferred)
Adolescent:
Similar to adult dosing, but use with caution on sensitive skin.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation of scaly skin. It also has humectant properties, attracting and retaining moisture in the skin, thereby increasing skin hydration and elasticity.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption (primarily local action)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (local action, minimal systemic elimination)
Clearance:
Not applicable
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Within days for softening of skin, full effect may take weeks for severe hyperkeratosis.
PeakEffect:
Varies with condition, typically within 1-2 weeks of consistent use.
DurationOfAction:
Effects persist as long as applied regularly; skin condition may revert if discontinued.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor for advice:
- Burning or stinging sensations
- Itching
- Irritation at the site where the medication was applied
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their online portal at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- Allergic reaction symptoms, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Other Possible Side Effects
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor for advice:
- Burning or stinging sensations
- Itching
- Irritation at the site where the medication was applied
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects
For medical advice regarding side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their online portal at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation that does not subside
- Rash or hives
- Swelling of the face, lips, or tongue (signs of allergic reaction)
- Worsening of the skin condition
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 as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medication list and health history with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medication list and health history with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 breastfeeding, 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 breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Local symptoms may include severe irritation, redness, and burning.
What to Do:
Discontinue use immediately. Wash the affected area with soap and water. If irritation persists or is severe, seek medical attention. For accidental ingestion, contact a poison control center (Call 1-800-222-1222 in the US).
Drug Interactions
Minor Interactions
- Other topical preparations (may increase absorption or cause irritation if applied concurrently)
Monitoring
Baseline Monitoring
Skin condition (e.g., dryness, scaling, thickness, presence of fissures)
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 (e.g., redness, burning, stinging, itching)
Frequency: Daily, especially during initial use.
Target: Absence of significant irritation.
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency or concentration if mild irritation persists.
Improvement in skin texture and hydration
Frequency: Weekly to bi-weekly.
Target: Softer, smoother, less scaly skin.
Action Threshold: Re-evaluate treatment plan if no improvement after 2-4 weeks.
Symptom Monitoring
- Burning sensation
- Stinging sensation
- Redness (erythema)
- Itching (pruritus)
- Skin irritation
- Allergic reaction (rare)
Special Patient Groups
Pregnancy
Urea 40% cream is generally considered safe for use during pregnancy due to minimal systemic absorption. Consult a healthcare provider before use.
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
Urea 40% cream is considered safe for use during lactation. Minimal systemic absorption means negligible transfer into breast milk. Avoid applying to areas where the infant may ingest it.
Infant Risk:
Low risk.
Pediatric Use
Use in children should be under the guidance of a healthcare professional, especially for infants and young children, as their skin may be more sensitive and permeable. Lower concentrations may be preferred.
Geriatric Use
No specific dose adjustments are typically needed for geriatric patients. However, elderly skin may be more fragile or sensitive, so monitor for irritation.
Clinical Information
Clinical Pearls
- Urea 40% cream is highly effective for conditions like psoriasis, eczema, ichthyosis, keratosis pilaris, and calluses/corns due to its dual keratolytic and humectant actions.
- For optimal results, apply to damp skin after bathing to lock in moisture.
- Occlusion (e.g., covering with a bandage or plastic wrap) can enhance penetration and efficacy for very thick lesions, but should only be done under medical supervision due to increased risk of irritation.
- Patients should be advised that a mild stinging or burning sensation may occur, especially on broken or inflamed skin, but it usually subsides with continued use. If severe, discontinue.
- Regular, consistent application is key for managing chronic hyperkeratotic conditions.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Alpha hydroxy acids (AHAs)
- Corticosteroids (topical, for inflammatory conditions)
- Retinoids (topical, e.g., tretinoin, tazarotene)
- Emollients and moisturizers (lower strength, for general dryness)
- Ammonium lactate (topical)
Cost & Coverage
Average Cost:
$15 - $50 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription plans as a Tier 1 or Tier 2 generic; may be available OTC.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.