Urea 20% Cream 85gm
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic, Emollient
Pharmacologic Class
Keratolytic agent, Humectant
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea 20% cream is a topical medication used to soften and moisturize very dry, rough, or scaly skin. It works by helping your skin hold onto moisture and by gently removing dead skin cells, making your skin 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 make sure it is completely dry.
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 the 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 make sure it is completely dry.
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 the 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 thoroughly before and after applying the cream.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds, broken, or severely inflamed skin unless directed by a healthcare professional.
- For best results, use regularly as directed.
- Consider using a gentle, non-irritating cleanser for affected areas.
- Avoid harsh soaps or excessive scrubbing that can further irritate the skin.
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 physician. Rub in until absorbed.
Condition-Specific Dosing:
hyperkeratosis:
Apply to thickened skin areas as directed.
xerosis:
Apply to dry, rough skin as needed for hydration.
Pediatric Dosing
Neonatal:
Not established (consult pediatrician, use with caution)
Infant:
Not established (consult pediatrician, use with caution)
Child:
Apply to affected skin areas 1-3 times daily, or as directed by physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected skin areas 1-3 times daily, or as directed by physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical use)
Moderate:
No adjustment needed (topical use)
Severe:
No adjustment needed (topical use)
Dialysis:
No specific considerations (topical use)
Hepatic Impairment:
Mild:
No adjustment needed (topical use)
Moderate:
No adjustment needed (topical use)
Severe:
No adjustment needed (topical use)
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that softens and dissolves the intercellular matrix of the stratum corneum, promoting desquamation of scaly skin. It also has humectant properties, attracting and holding moisture in the skin, thereby increasing skin hydration and elasticity. At 20% concentration, it primarily acts as a keratolytic and humectant.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% when applied to intact skin)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (primarily local action)
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:
Renal (for any systemically absorbed portion)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Skin softening and hydration effects may be noticeable within days. Keratolytic effects (e.g., reduction of scaling) may take 1-3 weeks of consistent use.
PeakEffect:
Varies depending on the severity of the condition and consistency of application.
DurationOfAction:
Requires continuous application for sustained therapeutic effect.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ 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 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 persist, contact your doctor for advice:
Burning or stinging
Itching
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ 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 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 persist, contact your doctor for advice:
Burning or stinging
Itching
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible 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.
Seek Immediate Medical Attention If You Experience:
- Severe burning, stinging, or irritation that does not go away.
- Increased redness or swelling of the treated area.
- Signs of an allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat).
- Signs of skin infection (e.g., pus, warmth, spreading redness).
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 exacerbate certain health problems.
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 existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction 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 medication may interact with other drugs or exacerbate certain health problems.
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 existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction 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.
In the event 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 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.
In the event 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 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:
- Excessive local skin irritation (e.g., severe burning, redness, peeling).
- Systemic overdose is highly unlikely due to minimal absorption.
What to Do:
If excessive local irritation occurs, wash the area thoroughly with water and discontinue use. If swallowed, call a Poison Control Center (1-800-222-1222) immediately, though systemic toxicity from ingestion of a small amount is generally low.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dryness, scaling, hyperkeratosis, or fissures.
Timing: Prior to initiation of therapy
Routine Monitoring
Improvement in skin texture and hydration
Frequency: Weekly to monthly, or as clinically indicated
Target: Reduced dryness, scaling, roughness; increased skin suppleness
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of therapy.
Local skin reactions (e.g., irritation, burning, redness, itching)
Frequency: Daily, or as symptoms occur
Target: Absence or minimal transient irritation
Action Threshold: Persistent or severe irritation, burning, redness, or signs of allergic reaction (e.g., swelling, rash) warrant discontinuation and medical evaluation.
Symptom Monitoring
- Skin dryness
- Scaling
- Roughness
- Fissures
- Itching
- Burning sensation
- Stinging sensation
- Redness
- Swelling
- Signs of allergic reaction (e.g., rash, hives)
Special Patient Groups
Pregnancy
Urea 20% cream is generally considered safe for use during pregnancy due to minimal systemic absorption. Pregnancy Category B.
Trimester-Specific Risks:
First Trimester:
Low risk.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Urea 20% cream is considered safe for use during lactation due to minimal systemic absorption. Avoid applying to the breast area if breastfeeding to prevent infant ingestion.
Infant Risk:
Low risk.
Pediatric Use
Use with caution in infants and young children, especially on large surface areas or broken skin, as their skin barrier is more permeable, potentially leading to increased systemic absorption. Consult a pediatrician before use in this age group.
Geriatric Use
No specific dosage adjustments or precautions are generally required for geriatric patients. Use as directed, monitoring for skin irritation.
Clinical Information
Clinical Pearls
- Urea cream is for external use only. Do not ingest.
- Avoid contact with eyes, mucous membranes (e.g., inside nose, mouth), and open wounds or severely irritated skin, as it may cause stinging or burning.
- Transient stinging or burning may occur upon initial application, especially on sensitive or broken skin. This usually subsides with continued use.
- For optimal results, apply to damp skin after bathing or showering to lock in moisture.
- Consistency is key; regular application is necessary to maintain therapeutic effects.
- Store at room temperature, away from excessive heat or cold.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Alpha hydroxy acids (AHAs)
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory skin conditions with scaling)
Cost & Coverage
Average Cost:
$15 - $50 per 85gm 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. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.