Urea 40% Cream 28.35gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic, Emollient
Pharmacologic Class
Keratolytic, 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 soften and remove rough, dry, or thickened skin, often found on the feet, hands, elbows, or knees. It helps to break down hard skin and also keeps the skin moisturized.
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.
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 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 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.
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 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 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 as directed by your doctor or pharmacist.
- Wash hands thoroughly 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, severely inflamed, or broken skin unless specifically instructed by a healthcare professional.
- For best results, apply regularly as prescribed.
- You may cover the treated area with a dressing if advised by your doctor, but avoid occlusive dressings unless specifically instructed, as they can increase absorption and irritation.
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 1 to 3 times daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply to thickened skin areas, gently rub in until absorbed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Consult pediatrician; use with caution on large areas or broken skin.
Child:
Apply to affected skin 1 to 3 times daily, or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected skin 1 to 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 agent that softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation of hyperkeratotic areas. It also acts as a humectant, attracting and retaining moisture in the skin, thereby increasing skin hydration and elasticity. At 40% concentration, its primary action is keratolytic.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption through intact skin. Absorption may be increased through broken, inflamed, or denuded skin.
Tmax:
Not applicable (primarily local topical effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily local topical effect)
ProteinBinding:
Not applicable (primarily local topical effect)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Minimal systemic excretion; primarily local action.
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Days to weeks for significant keratolytic and emollient effects.
PeakEffect:
Weeks of consistent application.
DurationOfAction:
Continues as long as applied; effects diminish upon discontinuation.
Confidence:
Medium
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:
- 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 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 or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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 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, or irritation at the application site
- Rash or allergic reaction (e.g., hives, swelling)
- Signs of skin infection (e.g., pus, worsening pain, fever)
- If skin condition worsens or does not improve after several weeks of use
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 this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in combination with them. 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 this information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions to confirm that it is safe to take this drug in combination with them. 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.
To ensure safe use, be aware that ingesting this drug 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 drug 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 to you and your baby.
To ensure safe use, be aware that ingesting this drug 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 drug 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 to you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
- Excessive local application may lead to increased skin irritation, redness, or burning.
What to Do:
Discontinue use and wash the affected area with water. If irritation persists, seek medical attention. For accidental ingestion or significant systemic exposure (highly rare), call 1-800-222-1222 (Poison Control Center) or seek emergency medical care.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To evaluate the severity of hyperkeratosis, dryness, or other skin conditions being treated.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin appearance (e.g., redness, irritation, peeling)
Frequency: Daily or as needed
Target: Reduction in hyperkeratosis, improved skin texture, minimal irritation
Action Threshold: Significant increase in redness, burning, itching, or signs of infection warrant discontinuation and medical evaluation.
Patient comfort and adherence
Frequency: Regularly during treatment
Target: Patient tolerates treatment well and applies as directed.
Action Threshold: Patient reports discomfort or non-adherence; adjust application frequency or consider alternative.
Symptom Monitoring
- Excessive redness
- Burning sensation
- Stinging
- Itching
- Peeling beyond desired exfoliation
- Signs of skin infection (e.g., pus, increased warmth, severe pain)
Special Patient Groups
Pregnancy
Urea is classified as Pregnancy Category B. Topical use is generally considered safe during pregnancy due to minimal systemic absorption. However, use should be under the guidance of a healthcare professional.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Urea is classified as L3 (moderately safe; limited data). Minimal systemic absorption is expected, making it unlikely to be excreted in breast milk in significant amounts. Generally considered compatible with breastfeeding, but caution should be exercised to avoid direct contact with the infant's skin or ingestion.
Infant Risk:
Low risk to infant due to minimal maternal systemic absorption.
Pediatric Use
Generally safe for use in children, but caution is advised, especially on large surface areas, broken skin, or in very young infants, due to potentially increased absorption. Consult a pediatrician for appropriate use and dosage.
Geriatric Use
No specific dosage adjustments are typically required for geriatric patients. However, older adults may have more fragile or sensitive skin, so monitor for increased irritation or adverse reactions.
Clinical Information
Clinical Pearls
- Urea 40% cream is highly effective for conditions like psoriasis, eczema, ichthyosis, keratosis pilaris, and calluses where significant keratolysis and hydration are needed.
- For optimal results, apply to clean, dry skin. Gentle rubbing can aid absorption.
- Transient stinging or burning may occur, especially on broken or inflamed skin. This usually subsides with continued use.
- Avoid using on acutely inflamed, denuded, or weeping skin unless specifically directed by a physician.
- Occlusive dressings can enhance the effect of urea but also increase the risk of irritation or absorption. Use only if prescribed.
- Patients should be advised that consistent, long-term use may be necessary for chronic conditions.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Alpha hydroxy acids (AHAs) (topical)
- Topical retinoids (e.g., tretinoin, tazarotene)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, dimethicone)
- Topical corticosteroids (for inflammatory components)
Cost & Coverage
Average Cost:
$15 - $50 per 28.35gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 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.