Nutraplus 10% Cream 85gm

Manufacturer BAUSCH HEALTH Active Ingredient Urea Cream and Ointment(yoor EE a) Pronunciation YOO-ree-uh
It is used to treat some skin problems. It is used to treat some nail problems.
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Drug Class
Keratolytic, Emollient, Humectant
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Pharmacologic Class
Keratolytic agent
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nutraplus 10% Cream is a skin cream containing urea, which helps to moisturize very dry, rough, or scaly skin. It works by helping your skin hold onto water, making it softer and smoother, and can also help remove dead skin cells.
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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.
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 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

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.
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Lifestyle & Tips

  • Apply to clean, dry skin.
  • Wash hands before and after application.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not apply to open wounds, severely cracked, or inflamed skin unless directed by a healthcare professional, as it may cause stinging or irritation.
  • For best results, apply regularly as directed.
  • Can be used after bathing to lock in moisture.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
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Pediatric Dosing

Neonatal: Not established (use with caution, consult pediatrician)
Infant: Not established (use with caution, consult pediatrician)
Child: Apply to affected skin areas 1 to 3 times daily, or as directed by a physician. Use with caution on large areas or broken skin.
Adolescent: Apply to affected skin areas 1 to 3 times daily, or as directed by a physician.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Urea is a keratolytic agent that softens and dissolves the horny layer of skin (stratum corneum) by increasing its water content. It acts as a humectant, attracting and holding moisture, and as an emollient, smoothing and softening the skin. At 10% concentration, it primarily functions as a humectant and emollient, aiding in rehydration of dry, rough, or scaly skin.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption through intact skin. Absorption may be increased through broken or inflamed skin.
Tmax: Not clinically relevant for topical use.
FoodEffect: Not applicable.

Distribution:

Vd: Not clinically relevant for topical use.
ProteinBinding: Not clinically relevant for topical use.
CnssPenetration: No

Elimination:

HalfLife: Not clinically relevant for topical use.
Clearance: Not clinically relevant for topical use.
ExcretionRoute: Renal (if absorbed systemically, but minimal absorption occurs).
Unchanged: Not clinically relevant for topical use.
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Pharmacodynamics

OnsetOfAction: Minutes to hours for initial hydration/emollient effect; days to weeks for significant keratolytic effect (softening of scales).
PeakEffect: Days to weeks, depending on the severity of the skin condition and consistency of application.
DurationOfAction: Varies with frequency of application and individual skin condition.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately
If you experience any of the following severe side effects, contact your doctor or seek medical attention right away, as they can be life-threatening. These may include:
- 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 monitor your body's response. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- Burning or stinging
- Itching
- Irritation at the site where the drug was applied

Important Note
This list does not include all possible side effects. If you have concerns about side effects, consult your doctor. For medical advice regarding 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning or stinging that does not subside
  • Increased redness or irritation
  • Development of a rash or hives
  • Signs of an allergic reaction (e.g., swelling, difficulty breathing, severe itching)
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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 other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 the event of accidental ingestion, immediately contact a doctor or a poison control center, as this medication can cause harm if swallowed. To minimize risks, avoid applying this medication to irritated skin, open wounds, or infected skin areas.

Using this medication too frequently can exacerbate your skin condition. Before applying any other drugs or products to your skin, including soaps, consult with your doctor to ensure safe and effective treatment.

If you are pregnant, planning to become pregnant, or are breast-feeding, discuss the potential benefits and risks of using this medication with your doctor, as this will help determine the best course of treatment for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive local skin irritation (e.g., severe redness, burning, peeling)
  • Systemic overdose is highly unlikely due to minimal topical absorption.

What to Do:

Discontinue use. Wash affected area with soap and water. For severe local reactions, seek medical attention. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical care.

Drug Interactions

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Minor Interactions

  • Other topical medications (may increase absorption of other topically applied drugs due to its keratolytic and humectant properties).

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dryness, scaling, hyperkeratosis, or other dermatological conditions.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Improvement in skin hydration and texture

Frequency: Daily to weekly, based on patient self-assessment and clinical observation.

Target: Reduced dryness, flaking, scaling; softer, smoother skin.

Action Threshold: Lack of improvement after several weeks of consistent use, or worsening of symptoms, warrants re-evaluation.

Local skin irritation (e.g., redness, burning, stinging, itching)

Frequency: Daily, especially during initial applications.

Target: Absence of significant irritation.

Action Threshold: Persistent or severe irritation, rash, or signs of allergic reaction warrant discontinuation and medical consultation.

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Symptom Monitoring

  • Skin dryness
  • Scaling
  • Flaking
  • Roughness
  • Itching
  • Redness
  • Burning sensation
  • Stinging sensation
  • Rash

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Consult a healthcare provider if pregnant or planning to become pregnant.

Trimester-Specific Risks:

First Trimester: Low risk.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Generally considered safe for use during lactation. Minimal systemic absorption means negligible amounts are expected to pass into breast milk. Avoid applying to areas where the infant may ingest the cream.

Infant Risk: Low risk.
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Pediatric Use

Can be used in children, but with caution, especially in infants and very young children, due to thinner skin and potentially increased absorption. Always consult a pediatrician before use in infants or on large body surface areas.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for geriatric patients. Use as directed for adults.

Clinical Information

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Clinical Pearls

  • Urea creams are highly effective for conditions characterized by dry, rough, or scaly skin, such as xerosis, ichthyosis, psoriasis, and eczema.
  • Transient stinging or burning may occur, especially on fissured or inflamed skin; this often subsides with continued use as the skin barrier improves.
  • Higher concentrations of urea (e.g., 20-40%) are typically used for more severe hyperkeratotic conditions (e.g., calluses, nail dystrophies) and have stronger keratolytic effects.
  • Regular and consistent application is key to achieving optimal results.
  • Can be used in conjunction with other topical therapies (e.g., corticosteroids) to enhance their penetration or improve skin hydration.
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Alternative Therapies

  • Other emollients (e.g., petrolatum, mineral oil, dimethicone-based creams)
  • Alpha hydroxy acids (e.g., lactic acid, glycolic acid)
  • Salicylic acid (for keratolytic effects)
  • Topical corticosteroids (for inflammatory conditions with dryness)
  • Ceramide-containing moisturizers
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Cost & Coverage

Average Cost: Low cost (typically $5-$20) per 85gm tube
Generic Available: Yes
Insurance Coverage: Not typically covered by prescription plans (Over-The-Counter product)
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.