Urea 40% Cream 198.4gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Emollient
Pharmacologic Class
Humectant; Keratolytic Agent
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea 40% Cream is a medicine applied to the skin to help soften and remove rough, dry, or scaly skin. It works by helping your skin shed dead cells and by attracting moisture to keep your skin hydrated.
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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly 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 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 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 once 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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly 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 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 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 once 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 broken skin unless directed by a healthcare professional.
- For external use only.
- Keep out of reach of children.
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 2 times daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply a thin layer to the affected area and rub in gently until absorbed. May be covered with an occlusive dressing if directed by a physician.
Pediatric Dosing
Neonatal:
Not established; use with caution and under medical supervision.
Infant:
Not established; use with caution and under medical supervision.
Child:
Apply to affected skin areas 1 to 2 times daily, or as directed by a physician. Use with caution in very young children due to potential for increased absorption through immature skin.
Adolescent:
Apply to affected skin areas 1 to 2 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that softens hyperkeratotic areas by dissolving the intercellular matrix of the stratum corneum, promoting desquamation. It also has humectant properties, attracting and holding moisture in the stratum corneum, thereby increasing skin hydration and elasticity.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <10%) following topical application to intact skin. Absorption may be increased with prolonged use, application to large surface areas, or to compromised skin.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local effect is immediate.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable (primarily local action).
ProteinBinding:
Not significant systemically.
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable for systemic half-life due to minimal absorption.
Clearance:
Not significant systemically.
ExcretionRoute:
Primarily local action; any absorbed urea is excreted renally.
Unchanged:
Not applicable for systemic unchanged excretion due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Within days for softening of skin; full keratolytic effect may take weeks.
PeakEffect:
Weeks of consistent use for optimal keratolytic and moisturizing effects.
DurationOfAction:
Dependent on continued application.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor for advice:
Burning or stinging
Itching
Irritation at the site where the medication was applied
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could be 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. However, many people do not experience any side effects or only have mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor for advice:
Burning or stinging
Itching
Irritation at the site where the medication was applied
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor.
Reporting Side Effects
You can 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 or irritation that worsens
- Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing - seek immediate medical attention)
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 medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
In the event of accidental ingestion, immediately contact a doctor or a poison control center, as this medication can be harmful if swallowed. To minimize potential risks, avoid applying this drug to irritated skin, open wounds, or infected skin areas.
Using this medication too frequently can exacerbate your skin condition. Before applying any other medications or products to your skin, including soaps, consult with your doctor to ensure safe and effective treatment.
If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of using this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
In the event of accidental ingestion, immediately contact a doctor or a poison control center, as this medication can be harmful if swallowed. To minimize potential risks, avoid applying this drug to irritated skin, open wounds, or infected skin areas.
Using this medication too frequently can exacerbate your skin condition. Before applying any other medications or products to your skin, including soaps, consult with your doctor to ensure safe and effective treatment.
If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of using this medication with your doctor, as this will help determine the best course of treatment for both you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
- Excessive topical application may lead to increased local irritation (e.g., severe burning, redness, peeling).
What to Do:
If excessive local irritation occurs, wash the area thoroughly with water and discontinue use. If ingested, seek medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Moderate Interactions
- Other topical keratolytics (e.g., salicylic acid, alpha hydroxy acids, retinoids): May increase skin irritation or dryness when used concurrently.
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., dryness, scaling, hyperkeratosis, presence of fissures)
Rationale: To establish baseline severity of dermatological condition and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical improvement of skin condition (e.g., reduced dryness, scaling, softening of hyperkeratotic areas)
Frequency: Periodically, as clinically indicated (e.g., weekly to monthly).
Target: Subjective improvement in skin texture and appearance.
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of diagnosis or treatment.
Local skin reactions (e.g., irritation, redness, stinging, burning, itching)
Frequency: Daily, especially during initial use.
Target: Absence of significant irritation.
Action Threshold: Persistent or severe irritation may necessitate reduction in frequency, temporary discontinuation, or use of a lower concentration.
Symptom Monitoring
- Redness
- Stinging
- Burning sensation
- Itching
- Irritation
- Peeling
- Allergic contact dermatitis (rare)
Special Patient Groups
Pregnancy
Urea 40% Cream is generally considered safe for use during pregnancy due to minimal systemic absorption. However, use should be based on clinical need and physician recommendation.
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 40% Cream is considered compatible with breastfeeding (L2) due to minimal systemic absorption by the mother and low likelihood of transfer into breast milk in clinically significant amounts. Avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk.
Pediatric Use
Use with caution in infants and young children, as their skin may be more permeable, potentially leading to increased absorption. Always use under medical supervision in this age group.
Geriatric Use
No specific dose adjustments are typically required. Elderly patients may have thinner, more fragile skin, so monitor for increased irritation.
Clinical Information
Clinical Pearls
- Urea 40% cream is highly effective for conditions like psoriasis, eczema, ichthyosis, and calluses due to its strong keratolytic and moisturizing properties.
- Patients should be advised that a mild stinging or burning sensation may occur, especially on initial application or to fissured skin, but this usually subsides.
- For best results, apply to damp skin after bathing, as this can enhance hydration.
- Occlusive dressings can enhance the effect of urea, but should only be used under medical guidance to avoid excessive absorption or irritation.
- Consistency of application is key for achieving and maintaining therapeutic benefits.
Alternative Therapies
- Other emollients (e.g., petrolatum, mineral oil, dimethicone)
- Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
- Salicylic acid (topical)
- Topical corticosteroids (for inflammatory conditions)
- Retinoids (topical, e.g., tazarotene, adapalene)
Cost & Coverage
Average Cost:
$20 - $60 per 198.4gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with 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 reporting the overdose, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it was taken.