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Theraplex

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
June 17, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
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 2019
Label revision date
June 17, 2019
Manufacturer
The Theraplex Company, LLC
Registration number
part348
NDC root
62917-819
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

Therplx3 is a medication designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can help alleviate discomfort associated with conditions such as eczema (a skin condition that causes red, itchy patches), seborrheic dermatitis (a type of skin inflammation), psoriasis (a chronic skin condition), and reactions to soaps, detergents, or cosmetics.

By targeting the underlying causes of itching, Therplx3 provides soothing relief, allowing you to feel more comfortable in your skin. However, it's important to consult with a doctor for any other uses of this product to ensure safe and effective treatment.

Uses

This product is designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You might find it helpful if you’re dealing with conditions like eczema, seborrheic dermatitis, psoriasis, or if your skin has reacted to soaps, detergents, or cosmetics.

While it can provide relief for these specific issues, it's important to remember that any other uses should be discussed with your doctor to ensure safety and effectiveness.

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 the best results.

However, if your child 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 younger children.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, and do not use it for diaper rash without consulting a doctor. If your condition worsens, persists for more than 7 days, or clears up and then returns within a few days, stop using the product and speak with a doctor. Additionally, keep this product out of reach of children; if 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 areas like diaper rash unless directed by a doctor. While using this product, be careful to keep it away from your eyes.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. It's also important not to start using any other hydrocortisone product without first speaking to your doctor.

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

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 that are not typical for the medication. If you notice any concerning changes in behavior or health, 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

When considering the use of Theraplex AIM Anti-Itch Moisturizing Cream (hydrocortisone cream) during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your specific situation. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and ensure that both you and your baby remain healthy.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without consulting a doctor first. Always prioritize your child's safety and seek professional advice if you're unsure.

Geriatric Use

While there is no specific information about the use of Theraplex AIM Anti-Itch Moisturizing Cream in older adults, it’s always wise 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 cream. This is especially important if you or your loved one has any underlying health conditions or is taking other medications.

Remember, your healthcare provider can help ensure that this product is safe and appropriate for your needs.

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 determine the best approach based on your liver function and overall health.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

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

When handling the product, make sure to do so 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 adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Therplx3 used for?

Therplx3 temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

How should I use Therplx3?

For adults and children 2 years of age and older, apply to the affected area no more than 3 to 4 times daily. Do not use it on children under 2 years of age without consulting a doctor.

Are there any warnings I should be aware of?

Yes, Therplx3 is for external use only. Avoid contact with eyes, and do not use for diaper rash without consulting a doctor. If symptoms worsen or persist for more than 7 days, stop use and consult a doctor.

What should I do if Therplx3 is swallowed?

Keep Therplx3 out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Is there any information about using Therplx3 during pregnancy or while nursing?

There is no specific information regarding the use of Therplx3 during pregnancy or lactation in the provided text.

What are the storage conditions for Therplx3?

Store Therplx3 at a temperature between 20° to 25°C (68° to 77°F).

Are there any contraindications for using Therplx3?

No contraindications are listed for Therplx3.

Packaging Info

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

Packaging configurations for Theraplex.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Therplx3 is a pharmaceutical compound characterized by its specific chemical properties and formulation. The molecular weight of Therplx3 is not specified in the provided data. The chemical formula is also not detailed. The drug is available in a dosage form suitable for its intended therapeutic use. Further information regarding its appearance and inactive ingredients is not included in the provided data.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, soaps, detergents, cosmetics, seborrheic dermatitis, and psoriasis.

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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a healthcare professional. In such cases, it is advisable to consult a doctor for appropriate guidance.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management in such cases.

Care should be taken to avoid contact with the eyes during application. If contact occurs, it is recommended to rinse the eyes thoroughly with water and seek medical attention if irritation persists.

Patients should be instructed 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 within a few days. It is important to advise patients against initiating the use of any other hydrocortisone products without prior consultation with a healthcare provider.

To ensure safety, this product should be kept out of 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 using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals are advised to consult a doctor for appropriate alternatives in such cases. Caution is advised to avoid contact with the eyes during application.

In the event that the condition being treated worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and seek medical advice. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Theraplex.
Details

Pediatric Use

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

Geriatric Use

There is no specific information regarding the use of Theraplex AIM Anti-Itch Moisturizing Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider individual patient factors when determining the appropriateness of this treatment for geriatric patients.

Pregnancy

There is currently no information available regarding the use of Theraplex AIM Anti-Itch Moisturizing Cream (hydrocortisone cream) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 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 of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. It is advisable to have the patient’s medical history and any relevant information about the ingested substance readily available to facilitate effective treatment.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's integrity.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Theraplex, 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 Theraplex, 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.