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Thera Plus Maximum Strength Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
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 2025
Label revision date
March 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
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 2025
Label revision date
March 4, 2025
Manufacturer
Fourstar Group USA, Inc.
Registration number
M017
NDC root
80684-145
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 temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as insect bites and irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides relief for external anal and genital itching.

While this drug is effective for these uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema and psoriasis, as well as reactions to poison ivy, oak, and sumac. It can also help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can relieve itching in external anal and genital areas. If you have other concerns or conditions, it's best to consult with your doctor for guidance on how to use this product safely.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this treatment.

For external itching in the anal and genital areas, adults should first clean the area gently with mild soap and warm water, then rinse thoroughly. After cleaning, pat the area dry with toilet tissue or a soft cloth before applying the medication. Again, you can apply it up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this medication in the genital area if you have a vaginal discharge or for treating diaper rash; it's important to consult a doctor in these cases. Additionally, do not exceed the recommended dosage unless directed by your healthcare provider. It's also crucial not to insert the medication directly into the rectum using your fingers or any device. Always prioritize your health and safety by following these guidelines.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, do not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a healthcare professional.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

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. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you suspect an overdose has occurred. Your safety is the top priority.

Pregnancy Use

You can use Thera Plus Maximum Strength Hydrocortisone Cream during pregnancy, as there are no specific warnings, precautions, or dosage changes mentioned for its use. The information provided does not indicate that the cream is contraindicated (not recommended) during pregnancy, nor does it suggest any risks to the fetus associated with its use.

However, it's always a good idea to consult with your healthcare provider before using any medication while pregnant to ensure it’s safe for you and your baby.

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 provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children between 2 and 12 years of age, you should also check with a doctor before using it.

For children aged 2 and older, you can apply the medication to the affected area, but make sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 68°F and 77°F (20°C to 25°C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any additional safety instructions provided with the device to ensure safe and effective use. If you have any questions about disposal or specific handling procedures, refer to the guidelines included with your product.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're treating external anal and genital itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication, also no more than 3 to 4 times daily.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, poison ivy, insect bites, and more.

Can I use this drug for external anal and genital itching?

Yes, this drug temporarily relieves external anal and genital itching. However, consult a doctor if you have a vaginal discharge or are treating diaper rash.

How should I apply this drug?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

What precautions should I take when using this product?

Avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. If symptoms worsen or persist for more than 7 days, consult a doctor.

What should I do if I swallow this product?

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

Is this drug safe to use during pregnancy?

The insert does not indicate any contraindications or risks associated with the use of this product during pregnancy.

What should I do if I experience rectal bleeding while using this product?

Stop using the product and consult a doctor if rectal bleeding occurs.

Packaging Info

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

Packaging configurations for Thera Plus Maximum Strength Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Thera Plus Maximum Strength Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the code 51945-4 and is associated with the effective date of December 27, 2024. The package labeling includes a visual representation, specifically an outer label in JPEG format. The outer label serves as a key component of the product's identification and presentation.

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, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital itching.

Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is 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; consultation with a physician is advised.

In cases of external anal and genital itching, adults should first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in patients with vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Furthermore, the product should not be used in excess of the directed dosage unless specifically instructed by a physician. Direct application into the rectum using fingers, mechanical devices, or applicators is also contraindicated.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. It is also not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes while using this product. It is imperative that patients adhere to the recommended dosage and not exceed the directed amount unless specifically advised by a physician.

Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated. Patients should be advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In the event of rectal bleeding, patients must stop use immediately and seek medical attention. It is essential to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised 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 within a few days. It is also crucial to seek medical advice if rectal bleeding occurs.

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 at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Thera Plus Maximum Strength Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children under 12 years of age, it is recommended to seek medical advice prior to use.

For adults and children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The use of Thera Plus Maximum Strength Hydrocortisone Cream during pregnancy has not been specifically addressed in terms of warnings, precautions, or dosage modifications. The available data does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. As such, healthcare professionals should consider the potential benefits and risks when recommending this product to women of childbearing potential. It is advisable to exercise caution and to discuss any concerns with patients regarding the use of this cream during pregnancy.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

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. The national Poison Control Center can be reached at 1-800-222-1222.

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 recovery.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a healthcare professional. Furthermore, patients should be made aware that they need to stop using the product and seek medical attention if rectal bleeding occurs.

While using the product, patients should be reminded to avoid contact with their eyes. It is essential to emphasize that they should not exceed the recommended dosage unless directed by a doctor. Lastly, patients should be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a range of 68 °F to 77 °F (20 °C to 25 °C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application, also not exceeding 3 to 4 times daily.

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 Thera Plus Maximum Strength Hydrocortisone, 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 Thera Plus Maximum Strength Hydrocortisone, 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.

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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.