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Nu-Derm Tolereen

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This product has been discontinued

Active ingredient
Hydrocortisone 5 mg/1 g
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1988
Label revision date
October 26, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 5 mg/1 g
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1988
Label revision date
October 26, 2011
Manufacturer
OMP, Inc.
Registration number
part348
NDC root
62032-112
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

TOLEREEN is an anti-pruritic lotion that contains 0.5% hydrocortisone, a medication designed to provide temporary relief from itching. This lotion is particularly helpful for minor skin irritations, inflammation, and rashes caused by conditions such as eczema, psoriasis, insect bites, and reactions to substances like soaps, poison ivy, poison oak, jewelry, cosmetics, and detergents.

If you're experiencing discomfort from any of these skin issues, TOLEREEN may help soothe your symptoms. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to give you temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You might find it helpful if you’re dealing with conditions like eczema or psoriasis, or if you've experienced itching from insect bites or contact with substances such as poison ivy, poison oak, or poison sumac. It can also soothe irritation from soaps, jewelry, cosmetics, and detergents.

While this product can be effective for these common issues, it's important to remember that any other uses should be discussed with your doctor to ensure safety and appropriateness for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

However, if the person needing treatment is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to young children.

What to Avoid

You should avoid using this product in your eyes, as it is not intended for that purpose. Additionally, do not use it for treating diaper rash. There are no specific contraindications or concerns regarding abuse, misuse, or dependence associated with this product, but it's always best to follow these guidelines to ensure safe and effective use.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to the eyes or used for treating diaper rash. If your symptoms persist for more than 7 days, worsen, or improve only to return after a few days, you should stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If it is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or using it for diaper rash. It's important to keep this product out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if your symptoms last longer than 7 days, worsen, or if they improve and then return after a few days. Always prioritize your health and safety by following these guidelines.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority, so don’t hesitate to get help.

Pregnancy Use

When it comes to using NU-DERM TOLEREEN (hydrocortisone lotion) during pregnancy, there is currently no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions noted about lactation or the possibility of the product being passed into breast milk. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your nursing infant.

Pediatric Use

If your child is under 2 years old, it's important not to use this product without consulting a doctor first. For children aged 2 years and older, you can apply the product to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of NU-DERM TOLEREEN (hydrocortisone lotion) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this medication. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be cautious when using this product. You should not start using any other hydrocortisone product while you are using this one, as combining them can lead to unwanted effects.

Additionally, there are no specific interactions with other medications or laboratory tests noted, but it's always a good idea to discuss all your current medications and any upcoming tests with your healthcare provider. This ensures that you receive safe and effective care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from freezing temperatures and excessive heat, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it is important to consult a doctor before use.

FAQ

What is TOLEREEN?

TOLEREEN is an anti-pruritic lotion containing 0.5% Hydrocortisone USP, used to provide temporary relief of itching.

What conditions can TOLEREEN help relieve?

TOLEREEN can relieve itching associated with minor skin irritations, inflammation, and rashes from conditions like eczema, psoriasis, insect bites, and reactions to soaps, poison ivy, and more.

How should I use TOLEREEN?

Apply TOLEREEN to the affected area not more than 3 to 4 times daily for adults and children 2 years and older. Do not use it on children under 2 years without consulting a doctor.

Are there any warnings for using TOLEREEN?

TOLEREEN is for external use only. Do not use it in the eyes or for the treatment of diaper rash.

What should I do if my symptoms do not improve?

Stop using TOLEREEN and ask a doctor if symptoms last for more than 7 days, worsen, or clear up and then come back.

How should I store TOLEREEN?

Store TOLEREEN at room temperature, protecting it from freezing and excessive heat.

Is TOLEREEN safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of TOLEREEN by nursing mothers.

Can I use other hydrocortisone products while using TOLEREEN?

When using TOLEREEN, do not begin the use of any other hydrocortisone product.

What should I do if TOLEREEN is swallowed?

If TOLEREEN is swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Nu-Derm Tolereen (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nu-Derm Tolereen.
Details

Drug Information (PDF)

This file contains official product information for Nu-Derm Tolereen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

OBAGI NU-DERM® TOLEREEN is an anti-pruritic lotion formulated with hydrocortisone USP at a concentration of 0.5%. This product is designed to alleviate itching and discomfort associated with various skin conditions. It is presented in a net weight of 2 ounces (57 grams).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes resulting from various conditions, including eczema, psoriasis, insect bites, seborrheic dermatitis, and reactions to soaps, poison ivy, poison oak, poison sumac, jewelry, cosmetics, and detergents.

Limitations of Use Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in or around the eyes is prohibited due to the potential for irritation or injury.

  • The product should not be used for the treatment of diaper rash, as it is not indicated for this condition.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used for the treatment of diaper rash.

Healthcare professionals are advised to instruct patients to discontinue use and seek medical advice if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then recur within a few days.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that the product is for external use only and should not be applied in or around the eyes. It is contraindicated for the treatment of diaper rash.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then recur within a few days.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

When using this product, it is advised that no other hydrocortisone products be initiated concurrently. This precaution is essential to avoid potential additive effects or complications associated with overlapping therapies.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not deemed necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nu-Derm Tolereen (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Nu-Derm Tolereen.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for NU-DERM TOLEREEN (hydrocortisone lotion). As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the general principles of pharmacotherapy in this population.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or changes in therapeutic response, given the variability in drug metabolism and sensitivity that can occur with aging.

Pregnancy

There is no specific information available regarding the use of NU-DERM TOLEREEN (hydrocortisone lotion) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk. As such, healthcare professionals may consider the use of this product in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, or if symptoms resolve and then return within a few days. Additionally, it is important to instruct patients not to initiate the use of any other hydrocortisone product while using this product, as this may lead to adverse effects or complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from freezing and excessive heat to maintain its integrity and efficacy. Proper handling is essential to prevent any compromise of the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Nu-Derm Tolereen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Nu-Derm Tolereen, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.