Urea Nail 45% Gel 28ml
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 45% gel is a medicine applied to the nails to help soften, loosen, and remove thick, hard, or diseased parts of the nail. It helps the nail become smoother and can make it easier for other nail treatments (like antifungals) to work.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
It is essential to apply this medication only to your nails, as directed. Do not ingest it, and avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing temperatures. Protect it from heat sources and keep the lid tightly closed when not in use.
Missing a Dose
If you forget to apply a dose, do so as soon as you remember. However, 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 application.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
It is essential to apply this medication only to your nails, as directed. Do not ingest it, and avoid getting it in your mouth, nose, or eyes, as it may cause irritation or burning.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing temperatures. Protect it from heat sources and keep the lid tightly closed when not in use.
Missing a Dose
If you forget to apply a dose, do so as soon as you remember. However, 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 application.
Lifestyle & Tips
- Wash and dry the affected nail(s) thoroughly before application.
- Apply a thin layer of gel to the entire surface of the affected nail(s), and if directed, under the tip of the nail.
- Rub in gently until absorbed, or as directed by your doctor.
- Some products may require covering the nail with a bandage or tape after application; follow specific product instructions.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to open wounds or irritated skin.
- Be patient; it may take several weeks to months to see significant improvement, especially for nail conditions.
- 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 a thin layer to affected nail(s) once or twice daily, or as directed by a physician. Cover with occlusive dressing if recommended.
Condition-Specific Dosing:
onychomycosis:
Apply to affected nail(s) once or twice daily, often in conjunction with antifungal agents.
dystrophic nails:
Apply to affected nail(s) once or twice daily to soften and debride.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult pediatrician)
Infant:
Not established (use with caution, consult pediatrician)
Child:
Apply a thin layer to affected nail(s) once or twice daily, or as directed by a physician. Use with caution, especially in younger children due to potential for increased systemic absorption through immature skin.
Adolescent:
Apply a thin layer to affected nail(s) once or twice daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Urea is a keratolytic agent that works by dissolving the intercellular matrix of the stratum corneum, promoting desquamation of hyperkeratotic areas. It also has humectant properties, increasing the water content of the skin and nails, leading to softening and loosening of the nail plate. At high concentrations (like 45%), it can cause chemical debridement of dystrophic or diseased nails.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from intact skin/nails; varies with concentration, vehicle, and skin integrity.
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:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically significant for topical application.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily renal for systemically absorbed amounts.
Unchanged:
Not clinically significant for topical application.
Pharmacodynamics
OnsetOfAction:
Softening of nails may be noticeable within days; full therapeutic effect (e.g., debridement) may take weeks to months.
PeakEffect:
Varies depending on the condition being treated and duration of use.
DurationOfAction:
Continuous application is required for sustained effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs and symptoms that may indicate a serious reaction:
- Allergic reaction symptoms, 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, 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 do not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor for advice:
- Burning or stinging
- Itching
- Irritation at the site where the medication 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 immediately or seek emergency medical attention. Although rare, some people may have severe and potentially life-threatening side effects when taking this medication. Be aware of the following signs and symptoms that may indicate a serious reaction:
- Allergic reaction symptoms, 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, 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 do not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual effects that bother you or do not go away, contact your doctor for advice:
- Burning or stinging
- Itching
- Irritation at the site where the medication 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, or irritation at the application site
- Redness or swelling that worsens
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/throat - seek immediate medical attention)
- Increased pain or signs of infection
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health 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 change 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health 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 change 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 treatment and do not use this drug for longer than recommended by your doctor.
To minimize potential risks, handle this medication with care, as swallowing it can be harmful. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
To minimize potential risks, handle this medication with care, as swallowing it can be harmful. If accidental ingestion occurs, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best possible outcome 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, redness, or peeling.
What to Do:
If excessive local irritation occurs, wash the area with soap and water and discontinue use. If ingested, seek medical attention or call a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Nail condition assessment
Rationale: To establish baseline severity of hyperkeratosis, dystrophy, or fungal infection.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin/nail irritation (redness, itching, burning, peeling)
Frequency: Daily, or with each application
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation occurs; consult physician if mild irritation persists.
Improvement in nail appearance/softness
Frequency: Weekly to monthly
Target: Gradual softening, thinning, or debridement of affected nail
Action Threshold: If no improvement after several weeks/months, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Redness around the nail
- Itching or burning sensation at the application site
- Pain or discomfort
- Excessive peeling or flaking of skin around the nail
- Signs of allergic reaction (rash, swelling)
Special Patient Groups
Pregnancy
Urea is 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
Urea is considered safe for topical use during lactation (L1) due to minimal systemic absorption. Avoid applying to areas where the infant may ingest the product.
Infant Risk:
Low risk
Pediatric Use
Generally safe for children, but use with caution, especially in infants and young children, as their skin may be more permeable, potentially leading to slightly higher systemic absorption. Consult a pediatrician for appropriate use and dosing.
Geriatric Use
No specific dose adjustments are typically needed for geriatric patients. Use with caution if skin is very thin or fragile, as irritation may be more likely.
Clinical Information
Clinical Pearls
- Urea 45% gel is particularly useful for thick, dystrophic nails, including those affected by onychomycosis, as it helps debride the nail, allowing better penetration of topical antifungals.
- Patience is key; significant improvement in nail appearance can take several months of consistent use.
- For best results, apply to clean, dry nails. Some formulations may recommend filing the nail surface before application.
- Occlusion (covering the nail with a bandage or tape after application) can enhance the keratolytic effect, but should only be done if specifically instructed by the product or physician.
- Advise patients to avoid getting the gel on surrounding healthy skin if possible, as it can cause irritation or peeling, especially with higher concentrations.
Alternative Therapies
- Salicylic acid (topical)
- Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
- Topical antifungals (for onychomycosis, e.g., efinaconazole, tavaborole, ciclopirox)
- Oral antifungals (for onychomycosis, e.g., terbinafine, itraconazole)
- Mechanical debridement of nails
- Surgical nail avulsion
Cost & Coverage
Average Cost:
$20 - $100+ per 28ml gel
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription plans, but may require prior authorization or be subject to tier restrictions. OTC versions are not typically covered.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about your 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 details about the medication taken, the amount, and the time it happened.