Urea 47% Cream 142gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Humectant
Pharmacologic Class
Keratolytic agent; Humectant
Pregnancy Category
Category B (for topical use, based on minimal systemic absorption)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is a topical medication used to soften and moisturize very dry, rough, or scaly skin. It helps to remove dead skin cells and improve the skin's ability to hold moisture, making it smoother and softer.
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, 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 lid tightly closed when not in use.
Missed Dose
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 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, 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 lid tightly closed when not in use.
Missed Dose
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 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.
- Do not apply to open wounds, broken, or inflamed 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 area 1 to 3 times daily, or as directed by a physician.
Condition-Specific Dosing:
xerosis:
Apply to dry, rough, or scaly skin.
hyperkeratosis:
Apply to thickened skin areas (e.g., calluses, corns, psoriasis plaques).
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); generally, apply sparingly to affected areas as directed by a physician.
Adolescent:
Apply to affected skin area 1 to 3 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that works by dissolving the intercellular matrix of the stratum corneum, which helps to loosen and shed scales and soften rough skin. It also acts as a humectant, attracting and retaining moisture in the skin, thereby increasing skin hydration and elasticity.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% from intact skin).
Tmax:
Not applicable (local action, minimal systemic absorption).
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Not applicable (minimal systemic absorption).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Local softening and hydration effects may be noticeable within hours to days of consistent application.
PeakEffect:
Optimal keratolytic and hydrating effects typically observed after several days to weeks of regular use.
DurationOfAction:
Effects persist as long as the product is applied regularly.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately:
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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Itching
Irritation at the site where the medication 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you manage any concerns.
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 immediately:
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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Itching
Irritation at the site where the medication 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects and help you manage any concerns.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation at the application site.
- Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
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 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 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 medication. Never start, stop, or change the dose 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 medication may interact with 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 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 medication. Never start, stop, or change the dose 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.
- Excessive application may lead to increased local irritation (e.g., redness, burning, peeling).
What to Do:
If excessive local irritation occurs, wash the area with water and discontinue use. If ingested, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention immediately, though systemic toxicity from topical urea is rare.
Drug Interactions
Monitoring
Baseline Monitoring
Skin assessment (dryness, scaling, hyperkeratosis, irritation)
Rationale: To establish baseline skin condition and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (hydration, softness, reduction in scaling/thickness)
Frequency: Daily to weekly, or as needed.
Target: Improved skin texture, reduced dryness/scaling.
Action Threshold: If no improvement or worsening of condition, reassess treatment.
Local skin irritation (redness, burning, itching)
Frequency: Daily.
Target: Absence of significant irritation.
Action Threshold: If severe or persistent irritation occurs, discontinue use and consult a healthcare professional.
Symptom Monitoring
- Skin dryness
- Scaling
- Roughness
- Thickened skin
- Itching
- Redness
- Burning sensation
- Stinging
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.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Generally considered safe for use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the cream.
Infant Risk:
Low risk.
Pediatric Use
Use in children should be under the guidance of a healthcare professional, especially for very young children or those with extensive skin conditions, due to potential for increased absorption through immature skin or large surface areas.
Geriatric Use
No specific dose adjustments are typically required for geriatric patients. Use with caution on very fragile or thin skin, as irritation may be more pronounced.
Clinical Information
Clinical Pearls
- Urea creams are highly effective for conditions like xerosis, ichthyosis, psoriasis, and hyperkeratotic skin conditions.
- Higher concentrations (e.g., 40-50%) are primarily keratolytic, while lower concentrations (e.g., 10-20%) are more humectant.
- May cause a transient stinging sensation, especially on abraded or inflamed skin.
- Occlusive dressings are generally not recommended unless specifically advised by a physician, as they can increase absorption and irritation.
- Patients should be advised to apply the cream after bathing when the skin is still slightly damp to maximize hydration.
Alternative Therapies
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
- Salicylic acid (for keratolytic effects)
- Topical corticosteroids (for inflammatory skin conditions)
Cost & Coverage
Average Cost:
Varies widely ($20 - $100+) per 142gm tube
Generic Available:
Yes
Insurance Coverage:
Often available OTC; prescription formulations may be covered as Tier 3 or 4, or require prior authorization.
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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.