Urea 10% Cream 85gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic, Emollient, Humectant
Pharmacologic Class
Keratolytic agent, Humectant
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is a topical medication that helps to soften rough, dry, or scaly skin. It works by helping your skin hold onto moisture and by gently removing dead skin cells, making your skin smoother and healthier.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
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 this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's potency.
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 scheduled 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 accompanying information carefully. It is essential to use this medication as directed to ensure safe and effective treatment.
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 this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's potency.
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 scheduled 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 thoroughly before and after application.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds or severely irritated skin unless directed by a healthcare professional.
- For external use only.
- Store at room temperature, away from excessive heat and moisture.
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 1-3 times daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply to thickened skin areas after cleansing, gently rubbing in until absorbed.
Pediatric Dosing
Neonatal:
Not established, consult pediatrician.
Infant:
Not established, consult pediatrician.
Child:
Apply to affected skin areas 1-3 times daily, or as directed by a physician.
Adolescent:
Apply to affected skin areas 1-3 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Urea is a keratolytic, humectant, and emollient. As a keratolytic, it softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation of scaly skin. As a humectant, it attracts and retains moisture in the skin. As an emollient, it helps to smooth and soften the skin, improving its barrier function. It also has mild anesthetic and antipruritic properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from intact skin (<5%). Absorption may increase with prolonged use, application to large surface areas, or on broken/inflamed skin.
Tmax:
Not clinically significant for topical application.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not clinically significant for topical application.
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 renal if systemically absorbed, but minimal absorption occurs.
Unchanged:
Not clinically significant for topical application.
Pharmacodynamics
OnsetOfAction:
Gradual, typically within days to weeks for noticeable improvement in skin texture and hydration.
PeakEffect:
Weeks of consistent use for optimal keratolytic and emollient effects.
DurationOfAction:
Dependent on continued application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a serious allergic reaction:
- 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
- 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 do not experience any side effects or only have mild ones, it's essential to monitor your response to the medication. 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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs of a serious allergic reaction:
- 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
- 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 do not experience any side effects or only have mild ones, it's essential to monitor your response to the medication. 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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. 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 that does not subside
- Redness
- Swelling
- Rash
- Signs of allergic reaction
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.
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 between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications 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.
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 between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications 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, and do not exceed the recommended treatment period.
To ensure safe use, be aware that ingesting this medication can be harmful. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
When applying this medication, avoid using it on irritated skin, open wounds, or infected skin, as this can exacerbate your condition. Additionally, using this medication too frequently can worsen your skin problem.
Before using 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.
To ensure safe use, be aware that ingesting this medication can be harmful. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
When applying this medication, avoid using it on irritated skin, open wounds, or infected skin, as this can exacerbate your condition. Additionally, using this medication too frequently can worsen your skin problem.
Before using 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to increased local irritation (burning, stinging, redness).
What to Do:
If ingested, call a Poison Control Center immediately (1-800-222-1222). For excessive topical application, wash the area with soap and water. If severe local irritation occurs, discontinue use and consult a healthcare professional.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of hyperkeratosis, dryness, or other dermatological conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation/redness
Frequency: Daily, with each application.
Target: Absence of irritation.
Action Threshold: Discontinue use if severe irritation, burning, or allergic reaction occurs.
Improvement in skin texture/hydration
Frequency: Weekly.
Target: Softer, smoother, less scaly skin.
Action Threshold: Re-evaluate treatment plan if no improvement after 2-4 weeks.
Symptom Monitoring
- Skin irritation
- Redness
- Burning sensation
- Stinging (especially on broken skin)
- Itching
- Allergic reaction (rash, swelling)
Special Patient Groups
Pregnancy
Urea cream is generally considered safe for topical use during pregnancy due to minimal systemic absorption. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Urea cream is generally considered safe for use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the cream (e.g., breast area).
Infant Risk:
Low risk.
Pediatric Use
Generally safe for children, but consult a pediatrician for use in infants or very young children, especially on large surface areas or broken skin. Dosing is typically similar to adults, but caution is advised.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Use with caution on very fragile or thin skin, as irritation may be more pronounced.
Clinical Information
Clinical Pearls
- Urea cream is highly effective for conditions characterized by dry, rough, or scaly skin, such as psoriasis, ichthyosis, eczema, and calluses.
- Higher concentrations (e.g., 20%, 40%) are available for more severe hyperkeratotic conditions, often requiring a prescription.
- Can cause a transient stinging or burning sensation, especially when applied to broken or inflamed skin. This usually subsides with continued use.
- Enhances the penetration of other topical medications, which can be beneficial but also requires caution if used with potent corticosteroids or other active ingredients.
- Regular, consistent use is key to achieving and maintaining therapeutic effects.
Alternative Therapies
- Lactic acid (e.g., AmLactin)
- Salicylic acid (for keratolytic effects)
- Alpha hydroxy acids (AHAs)
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions)
- Retinoids (for certain dermatological conditions)
Cost & Coverage
Average Cost:
$10 - $30 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as an over-the-counter (OTC) product, but may be covered with a prescription.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 happened.