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Thera Plus Eczema Hydrocortisone Anti Itch

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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
80684-146
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. Additionally, it provides relief from itching due to insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

You may also find this product useful for alleviating external anal and genital itching. However, for any other uses, it is important to consult with a doctor for proper guidance and supervision.

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 external itching in the 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 around the anal and genital areas, adults should first clean the area gently with mild soap and warm water, making sure to 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

It's important to use this product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. While using this product, make sure to avoid contact with your eyes. Additionally, do not exceed the recommended dosage unless your doctor advises you to do so. Lastly, refrain from inserting the product directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the product's effectiveness.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. 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 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 using it on any internal areas, especially if you have a vaginal discharge or diaper rash—consult your doctor in these cases. When applying the product, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using your fingers or any device.

If your condition worsens, 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, seek medical advice immediately. If the product is swallowed, get emergency help or contact a Poison Control Center at 1-800-222-1222 right away.

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 may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using Thera Plus Eczema Hydrocortisone Anti Itch cream during pregnancy, there is currently no information available about its safety, recommended dosage, 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 risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

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 experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children 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 issues related to external anal and genital itching, you should also consult a doctor if your child is under 12 years of age. Always prioritize your child's safety and seek professional advice when needed.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. 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 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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

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 specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

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're treating external anal and genital itching, first clean the area with mild soap and warm water, rinse thoroughly, and gently dry before applying the medication. This guidance applies to both adults and children aged 2 years and older.

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.

What should I do if I have a vaginal discharge?

Do not use this drug in the genital area if you have a vaginal discharge; consult a doctor.

How often can I apply this drug?

Adults and children 2 years and older can apply it to the affected area not more than 3 to 4 times daily.

Is this drug safe for children under 2 years old?

No, do not use this drug for children under 2 years of age without consulting a doctor.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What precautions should I take when using this product?

Avoid contact with eyes, do not use more than directed, and do not put it directly into the rectum.

What should I do if I swallow this drug?

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

What is the recommended storage temperature for this drug?

Store this drug at room temperature between 68 °F and 77 °F (20 °C to 25 °C).

Packaging Info

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

Packaging configurations for Thera Plus Eczema Hydrocortisone Anti Itch.
Details

Drug Information (PDF)

This file contains official product information for Thera Plus Eczema Hydrocortisone Anti Itch, 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 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 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 healthcare professional 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 cleaning, 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 healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is not recommended for individuals with vaginal discharge; consultation with a healthcare professional is advised.

  • The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is advised.

Additionally, the following precautions should be observed during use:

  • Avoid contact with eyes.

  • Do not exceed the recommended dosage unless directed by a healthcare professional.

  • The product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

When administering this product, it is imperative to avoid contact with the eyes. Patients should be instructed not to exceed the recommended dosage unless directed by a physician. Furthermore, the product should not be introduced directly into the rectum using fingers, mechanical devices, or applicators.

Patients must be advised to discontinue use and seek medical advice 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 also crucial to refrain from using any other hydrocortisone products without consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, patients should receive emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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.

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 with 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 Eczema Hydrocortisone Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Thera Plus Eczema Hydrocortisone Anti Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and genital itching, it is recommended that children under 12 years of age consult a doctor before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Thera Plus Eczema Hydrocortisone Anti Itch cream during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. 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.

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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

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

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 specific postmarketing experience details have been reported.

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 doctor. 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. They should also be instructed not to 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, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For external anal and genital itching, adults should first clean the affected area with mild soap and warm water, rinse thoroughly, gently dry, and then apply the medication as directed.

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 Eczema Hydrocortisone Anti Itch, 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 Eczema Hydrocortisone Anti Itch, 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.