Urea 10% Lotion 177ml
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Emollient; Humectant
Pharmacologic Class
Keratolytic; Humectant
Pregnancy Category
Not formally assigned for topical, generally considered low risk (similar to Category B)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea 10% lotion is a skin moisturizer and softener. It works by helping your skin hold onto water, making it less dry and flaky. It also helps to gently remove rough, dead skin cells, making your skin smoother.
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
Do not take this medication by mouth. It is for topical use on your skin only.
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, the treated area may be covered 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
Do not take this medication by mouth. It is for topical use on your skin only.
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, the treated area may be covered 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.
- Use regularly as directed for best results.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds or severely irritated skin.
- Wash hands thoroughly after application.
- For external use only.
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.
hyperkeratosis:
Apply to affected areas after cleansing, gently massaging until absorbed.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult pediatrician)
Infant:
Not established (use with caution, consult pediatrician)
Child:
Apply to affected areas 1 to 3 times daily, or as directed by a physician. Generally considered safe for children.
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 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 acts as a humectant, drawing moisture into the skin. At concentrations of 10% or higher, it also exhibits keratolytic properties, helping to loosen and shed dead skin cells, thereby softening and smoothing rough skin. It also helps to increase the water-binding capacity of the stratum corneum and can enhance the penetration of other topical agents.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 10% from intact skin)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
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:
Within days for softening and hydration, weeks for significant keratolytic effects.
PeakEffect:
Weeks to months of consistent use for optimal skin texture improvement.
DurationOfAction:
Effects persist with continued use; skin condition may revert upon discontinuation.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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 does not include all possible 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.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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 does not include all possible 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
- Irritation
- Rash
- Signs of allergic reaction (e.g., swelling, 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, 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.
* 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. 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.
* 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. 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.
To ensure safe use, be aware of the following precautions:
- Ingestion of this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.
- Avoid applying this medication to irritated skin, open wounds, or infected skin, as this can exacerbate your condition.
- Using this medication too frequently can worsen your skin problem. Follow the recommended usage instructions carefully.
- Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions.
- If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the benefits and risks of using this medication with your doctor to make an informed decision about its use.
To ensure safe use, be aware of the following precautions:
- Ingestion of this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.
- Avoid applying this medication to irritated skin, open wounds, or infected skin, as this can exacerbate your condition.
- Using this medication too frequently can worsen your skin problem. Follow the recommended usage instructions carefully.
- Before using any other medications or products on your skin, including soaps, consult with your doctor to avoid potential interactions.
- If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the benefits and risks of using this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Not expected with topical use due to minimal systemic absorption. Local irritation may occur if applied excessively or to broken skin.
What to Do:
Discontinue use and wash affected area with water. If irritation persists, seek medical attention. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity from ingestion of topical urea is unlikely.
Drug Interactions
Minor Interactions
- Other topical irritants (e.g., retinoids, alpha hydroxy acids): May increase skin irritation when used concurrently.
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, roughness, calluses)
Rationale: To assess the severity of the condition and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin hydration and texture
Frequency: Daily to weekly
Target: Improved softness, reduced scaling/roughness
Action Threshold: Lack of improvement or worsening of symptoms after 2-4 weeks of consistent use; onset of irritation.
Local skin irritation (redness, burning, stinging, itching)
Frequency: Daily
Target: Absence of irritation
Action Threshold: Persistent or severe irritation; discontinue use and consult healthcare provider.
Symptom Monitoring
- Dryness
- Scaling
- Roughness
- Itching
- Redness
- Burning sensation
- Stinging sensation
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
Considered safe for use during lactation. Minimal systemic absorption means negligible transfer into breast milk. Avoid applying to areas where the infant may ingest it.
Infant Risk:
Low risk
Pediatric Use
Generally safe for children, but use with caution in infants and neonates as skin barrier function may be immature, potentially leading to increased absorption. Consult a pediatrician for use in very young children.
Geriatric Use
No specific dose adjustments or precautions needed for geriatric patients. May be particularly beneficial for age-related dry skin (xerosis).
Clinical Information
Clinical Pearls
- Urea lotions are most effective when applied to damp skin after bathing to lock in moisture.
- Higher concentrations of urea (e.g., 20-40%) are used for more severe hyperkeratotic conditions like psoriasis, ichthyosis, or calluses, while 10% is good for general dry skin.
- Patients may experience a mild stinging sensation, especially on broken or very dry skin, which usually subsides with continued use.
- Consistent, daily application is key for achieving and maintaining results.
- Can be used in conjunction with other topical medications, but apply urea first and allow to absorb before applying other products, or as directed by a healthcare professional.
Alternative Therapies
- Lactic acid lotions (e.g., AmLactin)
- Alpha hydroxy acid (AHA) creams
- Salicylic acid topical preparations
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Ceramide-containing moisturizers
Cost & Coverage
Average Cost:
$10 - $30 per 177ml lotion
Generic Available:
Yes
Insurance Coverage:
Often OTC; if prescribed, typically Tier 1 or 2.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 discuss them with 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.