Urea 40% Lotion 226.8gm
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 B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea 40% lotion is a strong moisturizer and skin softener. It works by helping your skin hold onto water and by gently breaking down rough, thick skin. It's used to treat very dry, scaly, or thickened skin conditions like calluses, corns, and certain types of eczema or psoriasis.
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 desired, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
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 desired, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
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.
- Wash hands thoroughly after application.
- Avoid contact with eyes, nose, mouth, and open wounds or irritated skin.
- Do not use on broken or inflamed skin unless directed by a doctor.
- For best results, apply regularly as directed.
- Consider wearing cotton socks or gloves after applying to feet or hands to enhance absorption and prevent rubbing off.
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 once or twice daily, or as directed by a physician. Rub in until absorbed.
Condition-Specific Dosing:
hyperkeratosis:
Apply to thickened skin areas once or twice daily.
xerosis:
Apply to dry, rough skin areas once or twice daily.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult physician)
Infant:
Not established (use with caution, consult physician)
Child:
Apply to affected skin areas once or twice daily, or as directed by a physician. Use lower concentrations (e.g., 10-20%) for general dryness; 40% for specific hyperkeratotic conditions under medical supervision.
Adolescent:
Apply to affected skin areas once or twice 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 adjustment needed (topical application, minimal systemic absorption)
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 naturally occurring compound that is a potent humectant and keratolytic agent. As a humectant, it attracts and retains moisture in the stratum corneum, increasing skin hydration. As a keratolytic, at higher concentrations (like 40%), it denatures and solubilizes proteins, including keratin, leading to the softening and desquamation of hyperkeratotic skin. It also has mild anesthetic and antipruritic properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% typically)
Tmax:
Not applicable (topical effect)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic elimination)
Clearance:
Not applicable (minimal systemic elimination)
ExcretionRoute:
Not applicable (minimal systemic excretion)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Hours to days for softening effect; full keratolytic effect may take days to weeks of consistent use.
PeakEffect:
Days to weeks
DurationOfAction:
Depends on continued application; effects diminish upon discontinuation.
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. 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 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. 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.
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. 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 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. 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
- Redness
- Swelling
- Itching that worsens or does not go away
- Signs of allergic reaction (e.g., rash, hives, difficulty 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, any of 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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 it without consulting your doctor.
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 breastfeeding, it is crucial to discuss the benefits and risks of using this medication with your doctor to make an informed decision regarding 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 breastfeeding, it is crucial to discuss the benefits and risks of using this medication with your doctor to make an informed decision regarding you and your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local irritation, burning, or stinging.
What to Do:
If excessive local irritation occurs, wash the area with soap and water. If ingested, seek medical attention immediately or call a poison control center (1-800-222-1222). Ingestion of large amounts could potentially cause gastrointestinal upset, but is rare for a topical product.
Drug Interactions
Minor Interactions
- Other topical medications (may increase absorption or irritation of other topicals if applied concurrently on the same area)
Monitoring
Baseline Monitoring
Skin condition (e.g., dryness, scaling, thickness, fissures)
Rationale: To assess the severity of the condition and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin irritation (redness, burning, stinging, itching)
Frequency: Daily, with each application
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency or concentration if mild irritation persists.
Improvement in skin texture and appearance
Frequency: Weekly to bi-weekly
Target: Softer, smoother, less scaly skin
Action Threshold: Re-evaluate treatment plan if no improvement after 2-4 weeks.
Symptom Monitoring
- Skin redness
- Burning sensation
- Stinging sensation
- Itching
- Increased dryness or irritation
- Signs of allergic reaction (rash, swelling)
Special Patient Groups
Pregnancy
Urea is generally considered safe for topical use during pregnancy. Systemic absorption is minimal, limiting fetal exposure. Consult with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Urea is considered safe for topical use during lactation. Minimal systemic absorption means negligible transfer into breast milk. Avoid applying to areas where the infant may ingest it (e.g., nipples).
Infant Risk:
Low risk (L1)
Pediatric Use
Generally safe for children, but lower concentrations (e.g., 10-20%) are often preferred for general dryness. 40% urea should be used in children only under medical supervision for specific hyperkeratotic conditions, as their skin may be more sensitive and prone to irritation.
Geriatric Use
No specific dose adjustments are typically needed for geriatric patients. However, elderly skin may be more fragile and prone to irritation, so monitor for adverse reactions. Start with less frequent application if sensitivity is a concern.
Clinical Information
Clinical Pearls
- Urea 40% is highly effective for conditions requiring significant keratolysis, such as thick calluses, corns, severe dry cracked heels, and certain forms of psoriasis or ichthyosis.
- Patients should be advised that a mild stinging sensation may occur upon initial application, especially on fissured or very dry skin, but this usually subsides with continued use.
- For optimal results, apply to damp skin after bathing, or occlude the area (e.g., with cotton socks for feet) to enhance penetration.
- Avoid applying to open wounds, cuts, or severely inflamed skin, as it can cause significant burning and irritation.
- Regular, consistent use is key for achieving and maintaining therapeutic effects.
Alternative Therapies
- Salicylic acid (topical)
- Lactic acid (topical)
- Ammonium lactate (topical)
- Alpha hydroxy acids (AHAs)
- Topical corticosteroids (for inflammatory conditions)
- Emollients and moisturizers (lower strength urea, petrolatum, mineral oil)
Cost & Coverage
Average Cost:
$20 - $60 per 226.8gm (8oz) tube/jar
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription plans, may be Tier 1 or 2. Some formulations may be OTC.
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 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.