Urea 10% Hydrating Cream 85gm
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 available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea cream is a topical medication used to treat dry, rough, scaly skin conditions. It works by helping your skin hold onto water, making it softer and smoother, and by gently loosening dead skin cells.
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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly before and after applying the medication, unless your hand is the treated area, in which case you should not wash it 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 necessary, you can cover the treated area with a bandage or dressing.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's effectiveness.
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 ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Wash your hands thoroughly before and after applying the medication, unless your hand is the treated area, in which case you should not wash it 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 necessary, you can cover the treated area with a bandage or dressing.
Storage and Disposal
Store this medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the container tightly closed to maintain the medication's effectiveness.
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 as directed by your doctor or the product label.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not apply to broken, inflamed, or irritated skin unless specifically directed by a healthcare professional.
- Wash hands thoroughly after application.
- For external use only; do not ingest.
- For best results, apply after bathing or showering to lock in moisture.
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 1-3 times daily, or as directed by physician.
Condition-Specific Dosing:
dry skin:
Apply a thin layer to affected areas 1-3 times daily.
hyperkeratosis:
Apply a thin layer to affected areas 1-3 times daily, or as directed by physician for specific conditions.
Pediatric Dosing
Neonatal:
Not established
Infant:
Use with caution; consult pediatrician. Minimal systemic absorption expected.
Child:
Apply to affected areas 1-3 times daily, or as directed by physician.
Adolescent:
Apply to affected areas 1-3 times daily, or as directed by 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 for topical use.
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 helps to loosen and shed dead skin cells by dissolving the intercellular matrix of the horny substance in the stratum corneum. It also acts as a humectant, attracting and holding water in the stratum corneum, thereby increasing skin hydration and elasticity. At lower concentrations (e.g., 10%), its primary action is humectant and emollient, while at higher concentrations (e.g., 20-40%), its keratolytic properties become more prominent.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <5% of applied dose)
Tmax:
Not applicable (for systemic effects)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
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:
Skin softening and hydration effects can be noticed within days of consistent use. Keratolytic effects (for higher concentrations or more severe conditions) may take weeks.
PeakEffect:
Continuous with consistent application.
DurationOfAction:
Effects persist as long as the product is applied regularly.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
Note: This is not an exhaustive list of 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.
Although rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
Note: This is not an exhaustive list of 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 that does not subside
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble 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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A comprehensive list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A comprehensive list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 case 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 case 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:
- Local skin irritation (e.g., redness, burning, stinging) if applied excessively.
What to Do:
Discontinue use and wash the affected area. Symptoms are typically localized and resolve upon discontinuation. In case of accidental ingestion, contact a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (visual inspection)
Rationale: To assess baseline severity of dryness, scaling, roughness, or hyperkeratosis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (visual inspection)
Frequency: Daily or weekly, depending on severity and patient response.
Target: Improvement in skin hydration, reduction in scaling, roughness, or hyperkeratosis.
Action Threshold: Worsening of condition, development of irritation (redness, burning, stinging), or lack of expected improvement.
Symptom Monitoring
- Skin irritation
- Redness
- Burning sensation
- Stinging sensation
- Itching
- Signs of allergic reaction (rash, swelling)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. However, as with any medication, consult a healthcare professional before use if pregnant or planning to become pregnant.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Generally considered safe for topical use during lactation due to minimal systemic absorption. It is unlikely to be excreted in breast milk in significant amounts. Consult a healthcare professional before use.
Infant Risk:
Low risk. If applied to the breast area, ensure the area is clean before breastfeeding to prevent accidental ingestion by the infant.
Pediatric Use
Safe for use in older children and adolescents. Use with caution in infants and very young children due to thinner skin and potential for slightly increased absorption, though systemic effects are still minimal. Always consult a pediatrician before using on infants.
Geriatric Use
No specific dose adjustments are needed. Elderly patients may have more fragile or sensitive skin, so monitor for irritation or adverse reactions.
Clinical Information
Clinical Pearls
- Urea cream is highly effective for managing various dry, rough, and scaly skin conditions, including xerosis (dry skin), ichthyosis, psoriasis, eczema, and hyperkeratotic conditions like calluses and corns.
- While 10% urea primarily acts as a humectant and emollient, higher concentrations (e.g., 20%, 40%) are available for more severe hyperkeratotic conditions and may require a prescription.
- Mild stinging or burning sensation can occur upon initial application, especially on sensitive or broken skin. This usually subsides with continued use as the skin barrier improves.
- For optimal results, apply urea cream to damp skin immediately after bathing or showering to help seal in moisture.
- Consistent, regular application is key to achieving and maintaining therapeutic benefits.
Alternative Therapies
- Other emollients (e.g., petrolatum, mineral oil, dimethicone, ceramides)
- Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
- Salicylic acid (for keratolytic effects)
- Topical corticosteroids (for inflammatory skin conditions, often used in conjunction with emollients)
- Prescription retinoids (for certain hyperkeratotic conditions)
Cost & Coverage
Average Cost:
Varies widely by brand and retailer, typically $10-$30 per 85gm tube
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC), generally not covered by insurance unless prescribed for specific medical conditions.
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.