Urea 39% Cream 226.8gm
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 cream is a medication applied to the skin to help soften and moisturize very dry, rough, or scaly skin. It works by helping your skin hold onto water and by gently removing dead skin cells, making your skin smoother and healthier.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and 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 necessary, the treated area may be covered 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 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 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 the information provided. 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.
Keep the medication away from your mouth, nose, and 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 necessary, the treated area may be covered 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 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 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
- Wash and dry the affected skin area before applying the cream.
- Apply a thin layer of cream to the affected area and rub it in gently until absorbed.
- Use regularly as directed by your doctor or pharmacist for best results.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to open wounds, severely irritated, or broken skin unless specifically directed by a healthcare professional.
- Wash hands thoroughly after application.
- 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 to affected areas once or twice daily, or as directed by a physician.
Condition-Specific Dosing:
hyperkeratosis:
Apply a thin layer to the affected skin areas once or twice daily, or as directed by a physician. Rub in until completely absorbed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Use with caution; consult a physician. Skin barrier is thinner in infants.
Child:
Apply to affected areas once or twice daily, or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent:
Apply to affected areas 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 adjustment needed (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 promotes the softening and dissolution of the horny layer of the skin. It acts as a humectant, attracting and holding water in the stratum corneum, thereby increasing skin hydration. It also has mild proteolytic activity, which helps to break down keratin and loosen scales, facilitating desquamation of hyperkeratotic areas.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<10%)
Tmax:
Not applicable (topical, local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Primarily local action; minimal systemic excretion via kidneys if absorbed
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Softening of skin within hours; keratolytic effects noticeable within days to weeks of consistent use.
PeakEffect:
Varies depending on condition and consistency of use, typically within 1-2 weeks for significant improvement.
DurationOfAction:
Effects persist as long as product is applied regularly.
Safety & Warnings
Side Effects
Serious 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
- New or worsening rash, hives, or itching
- Swelling of the face, lips, or tongue (signs of allergic reaction)
- Signs of infection (e.g., pus, fever) if applied to broken skin
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.
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.
All medications you are currently taking, 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 these 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, 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.
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.
All medications you are currently taking, 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 these 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 breastfeeding, 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 breastfeeding, inform your doctor to weigh the benefits and risks of using this medication 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 burning.
What to Do:
If excessive local irritation occurs, wash the area with water and discontinue use. If ingested, seek immediate medical attention or call a poison control center (1-800-222-1222). Ingestion is unlikely to cause severe toxicity but may lead to gastrointestinal upset.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (visual inspection)
Rationale: To assess baseline severity of hyperkeratosis, dryness, or scaling.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin condition (visual inspection)
Frequency: Daily to weekly, or as needed
Target: Reduction in dryness, scaling, and thickness of affected skin
Action Threshold: If irritation, redness, or worsening of condition occurs, discontinue use and consult physician.
Patient comfort/adherence
Frequency: Regularly
Target: No significant burning, stinging, or discomfort
Action Threshold: If discomfort is persistent or severe, consider reducing frequency or discontinuing use.
Symptom Monitoring
- Skin irritation
- Redness
- Burning sensation
- Stinging
- Itching
- Peeling (excessive)
- Allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Considered safe for use during breastfeeding. Minimal systemic absorption means negligible excretion into breast milk. Avoid applying to areas where the infant may ingest it.
Infant Risk:
Low risk
Pediatric Use
Generally safe for older children and adolescents. Use with caution in infants and very young children due to thinner skin and potential for increased absorption, especially on large surface areas or broken skin. Consult a pediatrician.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. Use as directed for adults.
Clinical Information
Clinical Pearls
- Urea cream is highly effective for conditions like psoriasis, eczema, ichthyosis, and calluses due to its dual action as a humectant and keratolytic.
- Patients should be advised that a mild stinging or burning sensation may occur, especially on initial application to very dry or fissured skin, but this usually subsides.
- For best results, apply to damp skin after bathing to lock in moisture.
- Consistency is key; regular application is necessary to maintain therapeutic effects.
- Higher concentrations (e.g., 39-40%) are typically used for more severe hyperkeratosis, while lower concentrations (e.g., 10-20%) are used for general dry skin and maintenance.
Alternative Therapies
- Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
- Salicylic acid (topical)
- Ammonium lactate
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Corticosteroids (for inflammatory skin conditions)
- Retinoids (topical, for certain skin conditions)
Cost & Coverage
Average Cost:
$15 - $50 per 226.8gm tube
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance, may be Tier 1 or 2 for generic, Tier 3 for specific brands. May be OTC and not 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. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.