Nutraplus 10% Lotion 236ml
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
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Urea lotion is a skin softener and moisturizer. It helps to hydrate dry, rough, or scaly skin by drawing moisture into the skin and helping to remove dead skin cells, making your skin feel smoother and softer.
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.
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 that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
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, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
Keep the lid tightly closed.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or extra doses.
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.
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 that case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
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, you can cover the treated area with a bandage or dressing.
Before use, shake the medication well.
Storage and Disposal
To store this medication properly:
Keep it at room temperature.
Do not freeze the medication.
Protect it from heat.
Keep the lid tightly closed.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or extra doses.
Lifestyle & Tips
- Apply to clean, dry skin. For best results, apply after bathing while skin is still slightly damp.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not apply to broken, inflamed, or irritated skin unless directed by a healthcare professional.
- Wash hands thoroughly after application.
- Use regularly as directed for optimal results.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin areas 1-3 times daily, or as directed by a physician.
Condition-Specific Dosing:
xerosis:
Apply liberally to dry, rough, or calloused skin.
ichthyosis:
Apply to affected areas after bathing, while skin is still damp.
Pediatric Dosing
Neonatal:
Not established, consult pediatrician.
Infant:
Not established, consult pediatrician.
Child:
Apply to affected skin areas 1-3 times daily, or as directed by a physician. Use with caution on very young children due to potential for irritation.
Adolescent:
Apply to affected skin areas 1-3 times daily, or as directed by a physician.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Dialysis:
No adjustment needed for topical application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Pharmacology
Mechanism of Action
Urea is a humectant, drawing moisture into the skin, and a keratolytic agent, which helps to loosen and shed dead skin cells. It softens the horny layer of the skin (stratum corneum) by dissolving the intercellular matrix, which results in loosening of the dry, scaly skin. It also has mild antipruritic and antimicrobial properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from topical application (<10%)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Not well-defined for topical application.
CnssPenetration:
No
Elimination:
HalfLife:
Not well-defined for topical application.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal if systemically absorbed; most remains on skin surface.
Unchanged:
High percentage if absorbed systemically.
Pharmacodynamics
OnsetOfAction:
Within days for softening and hydration; keratolytic effects may take 1-2 weeks.
PeakEffect:
1-2 weeks of consistent use.
DurationOfAction:
Maintained with continued application.
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 of a severe allergic reaction:
- 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
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
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 of a severe allergic reaction:
- 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
- Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied
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 that does not subside
- Redness
- Swelling
- Signs of allergic reaction (e.g., rash, hives, 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.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, 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 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 drug may interact with other prescription or over-the-counter (OTC) medications, 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 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 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 are breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption.
- Excessive topical application may lead to increased local irritation (burning, stinging, redness).
What to Do:
If 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 not expected to cause severe toxicity but may cause gastrointestinal upset.
Drug Interactions
Minor Interactions
- Other topical preparations (may alter absorption or efficacy if applied concurrently)
Monitoring
Baseline Monitoring
Skin condition (dryness, scaling, 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 irritation (redness, burning, stinging)
Frequency: Daily, especially during initial use.
Target: Absence of significant irritation.
Action Threshold: Discontinue use if severe irritation occurs; reduce frequency or concentration if mild irritation persists.
Improvement in skin texture and hydration
Frequency: Weekly to monthly.
Target: Softer, smoother, less scaly skin.
Action Threshold: If no improvement after 2-4 weeks, reassess diagnosis or treatment plan.
Symptom Monitoring
- Skin irritation
- Redness
- Burning sensation
- Stinging sensation
- Itching
- Allergic reaction (rare)
Special Patient Groups
Pregnancy
Urea topical is generally considered safe for 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 topical is generally considered safe for use during lactation 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 on very young children or infants, especially on large surface areas or broken skin, as their skin barrier is more permeable. Consult a pediatrician for use in infants.
Geriatric Use
No specific dose adjustments or precautions are generally needed for geriatric patients. May be particularly beneficial for age-related dry skin conditions.
Clinical Information
Clinical Pearls
- Urea is effective for conditions characterized by dry, rough, or scaly skin, such as xerosis, ichthyosis, psoriasis, and eczema.
- Higher concentrations (e.g., 20-40%) are typically used for more severe keratolytic effects (e.g., calluses, nail dystrophies), while lower concentrations (e.g., 5-10%) are primarily for hydration and mild keratolysis.
- Patients should be advised that a mild stinging sensation may occur, especially on abraded or very dry skin, but it should subside.
- Regular, consistent use is key for achieving and maintaining therapeutic benefits.
Alternative Therapies
- Emollients (e.g., petrolatum, mineral oil, dimethicone)
- Humectants (e.g., glycerin, hyaluronic acid)
- Alpha hydroxy acids (AHAs) like lactic acid or glycolic acid
- Salicylic acid (for keratolytic effects)
- Topical corticosteroids (for inflammatory skin conditions)
Cost & Coverage
Average Cost:
$15 - $40 per 236ml lotion
Generic Available:
Yes
Insurance Coverage:
Often not covered by insurance as it is an over-the-counter (OTC) product, unless prescribed by a physician and deemed medically necessary.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.