Urea Hydrating 35% Foam
It is used to treat some skin problems. It is used to treat some nail problems.
Drug Class
Keratolytic; Emollient; Humectant
Pharmacologic Class
Urea derivative; Alpha-hydroxy acid (AHA)
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This foam contains urea and lactic acid, which work together to soften and moisturize very dry, rough, or thickened skin. It helps to break down hard skin cells and draw moisture into the skin, making it 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 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 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.
Shake the container well before use.
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 and sunlight. Do not freeze.
Keep the container tightly closed and protect it from puncture or burning, even if it appears empty.
Missed Dose
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 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.
Shake the container well before use.
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 and sunlight. Do not freeze.
Keep the container tightly closed and protect it from puncture or burning, even if it appears empty.
Missed Dose
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.
- Wash hands thoroughly before and after application.
- Avoid contact with eyes, lips, and other mucous membranes.
- Do not apply to open wounds, broken, or irritated skin.
- For external use only.
- Keep out of reach of children.
- Store at room temperature, away from heat and direct light.
- Regular use is key for best results.
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 skin areas once or twice daily, or as directed by a physician.
Condition-Specific Dosing:
Hyperkeratotic conditions (e.g., psoriasis, ichthyosis, eczema, dry/rough skin, calluses):
Apply a thin layer to the affected area and rub in gently. Use after bathing or showering for best results.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution and physician guidance due to sensitive skin)
Child:
Apply to affected skin areas once or twice daily, or as directed by a physician. Use with caution on sensitive skin.
Adolescent:
Apply to affected skin 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 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 promotes softening and dissolution of the horny layer of skin (stratum corneum). It increases the water content of the skin by acting as a humectant and by facilitating the breakdown of keratin. Lactic acid is an alpha-hydroxy acid (AHA) that also has keratolytic properties, promoting exfoliation of dead skin cells, and acts as a humectant, drawing moisture into the skin. The combination enhances hydration and desquamation, improving skin texture and reducing hyperkeratosis.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (topical)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (local action)
Clearance:
Not applicable (local action)
ExcretionRoute:
Not applicable (local action)
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Hours to days (for initial softening)
PeakEffect:
Days to weeks (for significant improvement in hyperkeratosis)
DurationOfAction:
Dependent on continued application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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. 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 immediate medical attention:
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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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. 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.
- New or worsening rash, itching, or swelling.
- Signs of infection (e.g., pus, increased pain, fever) if applied to compromised 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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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 allergic reaction you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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 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.
Be cautious when using this medication, as it is flammable. Keep it away from open flames and do not use it while smoking.
This medication may increase your susceptibility to sunburn. Exercise caution when exposed to sunlight, and notify your doctor if you experience increased sensitivity to the sun.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for 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.
Be cautious when using this medication, as it is flammable. Keep it away from open flames and do not use it while smoking.
This medication may increase your susceptibility to sunburn. Exercise caution when exposed to sunlight, and notify your doctor if you experience increased sensitivity to the sun.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Excessive local irritation (redness, burning, stinging, peeling)
- Rarely, systemic effects if applied to large areas of compromised skin, but highly unlikely with topical foam.
What to Do:
Discontinue use immediately. Wash the affected area with soap and water. If irritation persists, seek medical attention. For accidental ingestion, contact a poison control center (1-800-222-1222) or emergency services.
Drug Interactions
Moderate Interactions
- Other topical keratolytics (e.g., salicylic acid, retinoids): May increase irritation or excessive peeling.
Minor Interactions
- Topical corticosteroids: May enhance absorption of corticosteroids if applied concurrently to the same area (due to keratolytic effect).
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., dryness, scaling, thickness, fissures)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Skin hydration and texture
Frequency: Daily to weekly
Target: Improved softness, reduced scaling/thickness
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation.
Local skin irritation (e.g., redness, burning, stinging, itching)
Frequency: Daily
Target: Minimal to none
Action Threshold: Persistent or severe irritation warrants discontinuation or reduction in frequency.
Symptom Monitoring
- Increased redness
- Burning sensation
- Stinging
- Itching
- Excessive peeling or flaking
- Signs of allergic reaction (e.g., rash, swelling)
Special Patient Groups
Pregnancy
Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider.
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 (L1)
Pediatric Use
Use with caution in infants and young children due to more sensitive skin and higher surface area to volume ratio. Always consult a pediatrician before use in this population. Generally safe for older children and adolescents.
Geriatric Use
Generally safe for use in geriatric patients. No specific dose adjustments are typically needed. Monitor for increased skin sensitivity or irritation.
Clinical Information
Clinical Pearls
- This foam formulation can be particularly useful for larger body surface areas or hairy areas where creams/ointments are difficult to apply.
- Patients should be advised that a mild stinging sensation may occur upon initial application, especially on very dry or fissured skin, but it should subside.
- Consistent, daily application is crucial for achieving optimal keratolytic and moisturizing effects.
- Advise patients to avoid contact with eyes and mucous membranes, and to wash hands after application.
- Can be used as an adjunct to other dermatological therapies for conditions like psoriasis or eczema to improve skin barrier function and reduce scaling.
Alternative Therapies
- Salicylic acid (topical)
- Alpha-hydroxy acids (other, e.g., glycolic acid)
- Emollients and moisturizers (e.g., petrolatum, mineral oil, ceramides)
- Topical corticosteroids (for inflammatory conditions)
- Topical retinoids (e.g., tazarotene, adapalene)
Cost & Coverage
Average Cost:
$30 - $100+ per 100-150g foam
Generic Available:
Yes
Insurance Coverage:
Varies; often Tier 2-4 or not covered by insurance, may be covered as a medical benefit for specific conditions.
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets; consult with your pharmacist to determine if this applies to your prescription. If you have any questions or concerns about your medication, 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. Be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken, to facilitate prompt and appropriate treatment.