Urea 45% Cream 255gm
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
Pregnancy Category
Category B (Topical application, minimal systemic absorption expected)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is a medicine applied to the skin to help 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.
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 treated area, in which case you should not wash it 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, you can cover the treated area 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 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 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 treated area, in which case you should not wash it 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, you can cover the treated area 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 the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash and dry the affected skin area before applying the cream.
- Apply a thin layer of cream to the affected area and rub in gently until absorbed.
- Use regularly as directed by your doctor or pharmacist for best results.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to broken, inflamed, or irritated skin unless specifically directed by a healthcare professional.
- Wash hands thoroughly after application.
- For external use only. Do not ingest.
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.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
hyperkeratosis:
Apply to affected areas 1-3 times daily, rub in until absorbed.
xerosis:
Apply to dry skin areas 1-2 times daily.
Pediatric Dosing
Neonatal:
Not established (Use with caution, consult pediatrician for high concentrations)
Infant:
Not established (Use with caution, consult pediatrician for high concentrations)
Child:
Apply to affected skin areas 1 to 3 times daily, or as directed by a physician. Lower concentrations may be preferred.
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 (Topical application, minimal systemic absorption)
Moderate:
No adjustment needed (Topical application, minimal systemic absorption)
Severe:
No adjustment needed (Topical application, minimal systemic absorption)
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No adjustment needed (Topical application, minimal systemic absorption)
Moderate:
No adjustment needed (Topical application, minimal systemic absorption)
Severe:
No adjustment needed (Topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Urea is a keratolytic, humectant, and emollient. As a keratolytic, it softens the horny layer of the skin (stratum corneum) by dissolving the intercellular matrix, which loosens the dry, scaly, and hyperkeratotic tissue. This action facilitates the shedding of dead skin cells. As a humectant, it attracts and retains moisture in the skin, increasing its water-binding capacity. As an emollient, it helps to smooth and soften the skin, improving its texture and barrier function.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% from intact skin)
Tmax:
Not applicable for topical action; systemic Tmax not well-defined due to minimal absorption.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (primarily local action)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (primarily local action; systemic half-life not clinically relevant for topical use)
Clearance:
Not applicable (primarily local action)
ExcretionRoute:
Primarily local action; any minimally absorbed urea is excreted renally.
Unchanged:
Not applicable (primarily local action)
Pharmacodynamics
OnsetOfAction:
Days to weeks for noticeable softening and reduction of scaling.
PeakEffect:
Weeks to months with consistent use for optimal skin improvement.
DurationOfAction:
Dependent on continued application; effects diminish upon discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help 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 attention 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 attention 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.
- Development of a new rash or worsening of existing skin condition.
- Signs of an allergic reaction such as swelling, severe itching, or difficulty breathing (rare).
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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication 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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication 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.
If ingested, this medication can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
To minimize potential adverse effects, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Overuse of this medication can exacerbate your skin condition; therefore, it is crucial to follow the recommended usage guidelines.
Before using other medications or products on your skin, including soaps, consult with your doctor to ensure safe and effective treatment. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your treatment and the well-being of your baby.
If ingested, this medication can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.
To minimize potential adverse effects, avoid applying this medication to irritated skin, open wounds, or infected skin areas. Overuse of this medication can exacerbate your skin condition; therefore, it is crucial to follow the recommended usage guidelines.
Before using other medications or products on your skin, including soaps, consult with your doctor to ensure safe and effective treatment. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your treatment and the well-being of your baby.
Overdose Information
Overdose Symptoms:
- Excessive local irritation (burning, stinging, redness)
- Skin maceration (softening and breakdown of skin due to prolonged moisture)
What to Do:
Discontinue use and wash the affected area with water. If irritation persists, consult a healthcare professional. Systemic overdose is highly unlikely with topical application. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., dryness, scaling, hyperkeratosis)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of skin improvement (e.g., reduced scaling, increased hydration)
Frequency: Weekly to monthly, or as needed based on patient response
Target: Improved skin texture, reduced dryness and scaling
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of treatment plan.
Local skin irritation (e.g., redness, burning, stinging)
Frequency: Daily, especially during initial use
Target: Minimal to no irritation
Action Threshold: Persistent or severe irritation may warrant discontinuation or reduction in frequency.
Symptom Monitoring
- Skin dryness
- Scaling
- Roughness
- Itching
- Redness
- Burning sensation
- Stinging sensation
- Signs of allergic reaction (e.g., rash, swelling)
Special Patient Groups
Pregnancy
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, minimal systemic absorption.
Second Trimester:
Low risk, minimal systemic absorption.
Third Trimester:
Low risk, minimal systemic absorption.
Lactation
Considered compatible with breastfeeding. Minimal systemic absorption means negligible amounts are expected to pass into breast milk. Avoid applying to areas where the infant may ingest it.
Infant Risk:
Low risk
Pediatric Use
Generally safe for children, but high concentrations (like 45%) should be used with caution and under medical supervision, especially in very young children or infants, due to potentially increased absorption through thinner skin or risk of irritation. Lower concentrations are often preferred for pediatric use.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Use as directed, monitoring for skin irritation, which may be more common in fragile skin.
Clinical Information
Clinical Pearls
- Urea cream is highly effective for conditions like psoriasis, eczema, ichthyosis, and calluses due to its keratolytic and moisturizing properties.
- Higher concentrations (e.g., 40-50%) are typically used for severe hyperkeratosis, calluses, and nail dystrophies, while lower concentrations (e.g., 10-20%) are used for general dry skin and maintenance.
- Applying urea cream to damp skin after bathing can enhance its moisturizing effects.
- Avoid applying to open wounds, cuts, or severely inflamed skin as it can cause significant stinging or burning.
- Consistent, long-term use is often necessary for chronic conditions to maintain skin health and prevent recurrence of symptoms.
Alternative Therapies
- Salicylic acid (keratolytic)
- Lactic acid (alpha hydroxy acid, humectant/keratolytic)
- Ammonium lactate (humectant/keratolytic)
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory conditions)
- Calcipotriene (for psoriasis)
Cost & Coverage
Average Cost:
$15 - $50 per 255gm tube
Generic Available:
Yes
Insurance Coverage:
Often available over-the-counter (OTC) or may be covered as a Tier 1 or Tier 2 prescription by some insurance plans if prescribed by a physician.
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.