Urea 10% Lotion 240ml
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Emollient; Moisturizer
Pharmacologic Class
Humectant; Keratolytic agent
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea lotion is a moisturizer that helps soften and hydrate dry, rough, or scaly skin. It works by attracting water to the skin and helping to loosen dead skin cells, making your skin feel smoother.
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.
Apply this medication only to your skin. 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 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 desired, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
Ensure the lid is tightly closed.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, 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 use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed.
Apply this medication only to your skin. 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 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 desired, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
Ensure the lid is tightly closed.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, 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.
Lifestyle & Tips
- For external use only. Avoid contact with eyes, lips, and other mucous membranes.
- Do not apply to broken, inflamed, or irritated skin unless directed by a healthcare professional.
- Wash hands thoroughly before and after application.
- Apply after bathing or showering for best results, while skin is still damp.
- Use regularly as directed to maintain skin hydration and softness.
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 areas 1 to 3 times daily, or as directed by a physician.
Condition-Specific Dosing:
dry skin:
Apply liberally to dry, rough, or calloused skin areas.
ichthyosis:
Apply as directed, often after bathing.
Pediatric Dosing
Neonatal:
Not established, consult pediatrician.
Infant:
Use with caution, consult pediatrician. Generally, lower concentrations may be used.
Child:
Apply to affected areas 1 to 3 times daily, or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected 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 naturally occurring component of the skin's natural moisturizing factor (NMF). When applied topically, it acts as a humectant, attracting and retaining water in the stratum corneum, thereby increasing skin hydration. At concentrations of 10% or higher, it also exhibits keratolytic properties by dissolving the intercellular matrix of the stratum corneum, promoting desquamation and softening hyperkeratotic areas. This helps to loosen and shed dead skin cells, improving skin texture and reducing scaling.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5%) when applied to intact skin.
Tmax:
Not clinically significant for topical application.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not clinically significant for topical application.
ProteinBinding:
Not clinically significant for topical application.
CnssPenetration:
Limited (not clinically relevant for topical use).
Elimination:
HalfLife:
Not clinically significant for topical application.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily local action; minimal systemically absorbed urea is excreted renally.
Unchanged:
Not applicable for topical use.
Pharmacodynamics
OnsetOfAction:
Moisturizing effect: Immediate; Keratolytic effect: Days to weeks depending on condition.
PeakEffect:
Moisturizing effect: Within hours; Keratolytic effect: Varies with condition and concentration.
DurationOfAction:
Varies with skin condition and frequency of application.
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
- 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, 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
- 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, or irritation that does not subside.
- Development of a rash or allergic reaction (e.g., hives, swelling).
- Signs of infection if applied to broken skin (e.g., pus, increased pain, fever).
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 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.
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 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 the event of accidental ingestion, immediately contact a doctor or a poison control center, as this medication can cause harm 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 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 cause harm 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 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption.
- Excessive application may lead to increased local irritation (burning, stinging, redness).
What to Do:
If ingested, seek immediate medical attention or contact a poison control center (e.g., 1-800-222-1222). For excessive topical irritation, wash the area with water and discontinue use. Symptomatic and supportive care.
Drug Interactions
Minor Interactions
- Other topical irritants (may increase skin irritation)
- Topical corticosteroids (may enhance absorption of corticosteroids if applied to same area)
Monitoring
Baseline Monitoring
Skin condition assessment (dryness, scaling, hyperkeratosis)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin irritation (redness, burning, stinging, itching)
Frequency: Daily, especially during initial use.
Target: Absence of significant irritation.
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency or concentration if mild irritation persists.
Improvement in skin hydration and texture
Frequency: Weekly to monthly, or as needed.
Target: Reduced dryness, scaling, and roughness.
Action Threshold: If no improvement after several weeks, re-evaluate diagnosis or consider alternative therapies.
Symptom Monitoring
- Skin redness
- Burning sensation
- Stinging sensation
- Itching
- Increased dryness
- Rash
- Swelling
Special Patient Groups
Pregnancy
Urea topical is generally considered safe for use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Low risk.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Urea topical is considered safe for use during lactation due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the product (e.g., nipples).
Infant Risk:
Low risk.
Pediatric Use
Generally safe for use in children, but caution should be exercised, especially in infants and on large surface areas or broken skin, due to potentially increased absorption. Consult a pediatrician for specific guidance.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically required. Elderly skin may be more fragile, so monitor for irritation.
Clinical Information
Clinical Pearls
- Urea concentration matters: 5-10% for moisturizing/emollient effects, 20-40% for keratolytic effects (e.g., for calluses, thick scales).
- Can cause mild stinging or burning, especially on sensitive or broken skin. This usually subsides with continued use.
- Often used as an adjunct therapy for conditions like eczema, psoriasis, ichthyosis, and xerosis (dry skin).
- Enhances penetration of other topical medications, so apply other products separately or as directed.
- For best results, apply to damp skin after bathing.
Alternative Therapies
- Lactic acid lotions (e.g., AmLactin)
- Alpha hydroxy acid (AHA) lotions
- Salicylic acid topical preparations
- Emollients (e.g., petrolatum, mineral oil, dimethicone-based creams)
- Humectants (e.g., glycerin, hyaluronic acid)
- Topical corticosteroids (for inflammatory conditions)
Cost & Coverage
Average Cost:
$10 - $30 per 240ml lotion
Generic Available:
Yes
Insurance Coverage:
Typically OTC, not covered by prescription insurance. May be eligible for FSA/HSA.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.