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Total Relief

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Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Shampoo
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
November 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Drug class
Corticosteroid
Dosage form
Shampoo
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 2022
Label revision date
November 11, 2023
Manufacturer
DR. MARDER SKINCARE, LLC
Registration number
M017
NDC root
71516-342
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

This medication is designed to help control the symptoms of scalp itch that can occur due to minor skin irritations and rashes. It is particularly associated with conditions like seborrheic dermatitis (a common skin condition that causes scaly patches and red skin), eczema (a condition that makes your skin red and itchy), and psoriasis (a chronic autoimmune condition that leads to the rapid growth of skin cells).

By targeting these specific skin issues, this treatment aims to provide relief and improve your comfort. If you're experiencing scalp itch related to these conditions, this medication may be a helpful option for you.

Uses

If you're dealing with an itchy scalp caused by minor skin irritations or rashes, this medication can help. It's effective for conditions like seborrheic dermatitis, eczema, and psoriasis, providing relief from the discomfort associated with these issues.

You can expect this treatment to assist in managing the symptoms, allowing you to feel more comfortable in your daily life. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

To use this shampoo effectively, start by wetting your hair thoroughly. Then, apply a generous amount of the shampoo to your scalp and lather it well for several minutes. Make sure to rinse it out completely. For best results, you should repeat this process.

After shampooing, follow up with the Step 2 Total Relief Conditioner to help nourish and manage your hair. You can use this shampoo daily if needed, ensuring your hair stays clean and healthy.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return, you should stop using the medication and consult your doctor. Additionally, make sure to avoid any contact with your eyes, as this could lead to irritation or other issues.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these instructions closely.

Side Effects

When using this product, it's important to remember that it is for external use only. Be careful to avoid contact with your eyes. If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return, 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 help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that may come into contact with your eyes. If you notice that your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return, it’s important to stop using the product and consult your doctor.

In the event that the product is swallowed, seek medical assistance immediately or contact a Poison Control Center for guidance. Your safety is a priority, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior. If you notice anything concerning, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

While the provided information does not specify any particular guidelines or safety concerns regarding the use of this medication during pregnancy, it is always important to approach any medication with caution if you are pregnant or planning to become pregnant. You should consult your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions about your health and the health of your baby.

Remember, your healthcare provider can offer personalized advice and may suggest alternative treatments or precautions based on your specific situation. Always prioritize open communication with your medical team regarding any medications you are considering during pregnancy.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this shampoo for children aged 2 years and older, make sure to wet their hair thoroughly first. Apply a generous amount of shampoo, lather it into the scalp for several minutes, and then rinse it out completely. You can use the shampoo daily if necessary.

Always keep the product out of reach of children to prevent accidental ingestion. If your child swallows any of the shampoo, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of Total Relief Hydrocortisone Shampoo in older adults, it's important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this product. They can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team has a complete understanding of your health and can provide the best care possible.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your safety and well-being are the top priority, and discussing your medications helps to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20° and 25° C (68° and 77° F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

For effective use of this shampoo, you should apply it topically. Start by wetting your hair thoroughly, then generously lather the shampoo into your scalp for several minutes before rinsing it out completely. If necessary, you can repeat this process. It is recommended to use the shampoo daily if needed, for both adults and children aged 2 years and older.

FAQ

What is the primary use of this shampoo?

This shampoo helps control the symptoms of scalp itch associated with minor skin irritations and rashes due to conditions like Seborrheic Dermatitis, Eczema, and Psoriasis.

How should I use this shampoo?

Wet your hair thoroughly, apply the shampoo, generously lather your scalp for several minutes, and then rinse thoroughly. You can repeat this process and use it daily if needed.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes, and stop use if the condition worsens or symptoms persist for more than 7 days.

What should I do if I accidentally swallow the shampoo?

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

Is this shampoo safe for children?

This shampoo is suitable for adults and children 2 years of age and older.

Are there any known drug interactions?

No specific drug interactions are mentioned in the insert.

Can I use this shampoo during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of this product in pregnancy or nursing mothers.

What should I do if my symptoms return after using the shampoo?

If your symptoms clear up and then occur again, you should stop use and ask a doctor.

How should I store this shampoo?

Store the shampoo at room temperature between 20° - 25° C (68° - 77° F).

Packaging Info

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

Packaging configurations for Total Relief.
Details

Drug Information (PDF)

This file contains official product information for Total Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the control of symptoms associated with scalp itch due to minor skin irritations and rashes. Specifically, it is effective in managing symptoms related to seborrheic dermatitis, eczema, and psoriasis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should wet hair thoroughly before application. A generous amount of shampoo should be applied to the scalp, ensuring to lather for several minutes. It is important to rinse the hair thoroughly after lathering. This process should be repeated as necessary.

Following the shampoo application, it is recommended to use Step 2 Total Relief Conditioner to enhance the treatment.

The shampoo may be used daily if needed, depending on the individual's condition and response to treatment.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur. Additionally, contact with the eyes should be avoided to prevent irritation or injury.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental eye contact, immediate rinsing with water is recommended.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur.

In cases of ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Prompt action is essential to ensure patient safety and appropriate management of any adverse effects.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes during application. In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur, patients are advised to stop use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. If ingested, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Total Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the shampoo as directed. It is recommended to wet hair thoroughly, apply the shampoo generously, lather the scalp for several minutes, and rinse thoroughly. This process may be repeated as necessary, and the shampoo can be used daily if needed.

Caution should be exercised to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of Total Relief Hydrocortisone Shampoo, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of detailed data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this therapy in the geriatric population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, it is important to remind patients to avoid contact with their eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20° to 25° C (68° to 77° F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

The product is administered topically. For adults and children aged 2 years and older, the recommended application involves thoroughly wetting the hair, applying the shampoo, generously lathering the scalp for several minutes, and rinsing thoroughly. This process may be repeated as necessary, with daily use recommended if needed.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Total Relief, 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 Total Relief, 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.