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Thera Plus Anti-Itch with Aloe 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 2022
Label revision date
October 26, 2023
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 2022
Label revision date
October 26, 2023
Manufacturer
Fourstar Group USA, Inc.
Registration number
M017
NDC root
80684-038
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 various conditions, including eczema (a condition that makes your skin red and itchy), psoriasis (a skin disease that causes red, itchy scaly patches), and reactions to poison ivy, oak, or sumac. Additionally, it can soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis (a skin condition that causes scaly patches and red skin).

You may also find this product useful for relieving external anal and genital itching. However, it's important to consult with a doctor for any other uses to ensure safety and effectiveness.

Uses

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

Additionally, this product can temporarily relieve itching in external anal and genital areas. For any other uses, it's important to consult with your doctor for advice and supervision.

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 best to consult a doctor before using it.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, do not exceed the recommended dosage unless your doctor advises you to do so. Avoid inserting the product directly into the rectum using your fingers or any device.

While using this product, be careful to keep it away from your eyes to prevent irritation. Always prioritize your health and consult a healthcare professional if you have any concerns.

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 persist for more 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.

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 clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice. In case of accidental swallowing, get medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for assistance. 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 seek immediate medical help. Your safety is the top priority, so getting prompt assistance is crucial.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this cream is contraindicated (not recommended) for pregnant individuals, nor does it state any known risks to the fetus.

However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy 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 best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 years, you should also seek medical advice. For those aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always prioritize your child's safety by following these guidelines.

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 for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health effectively.

Storage and Handling

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

When handling the product, be sure to check the packaging carefully. It features a tamper-evident foil seal, which means you should not use it if the seal is broken or missing, as this could indicate that the product has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market.

FAQ

What conditions can this drug help 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.

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.

Are there any contraindications for using this drug?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

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

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding the use of this drug during pregnancy.

What precautions should I take when using this drug?

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

What should I do if I accidentally swallow this drug?

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

How should I store this drug?

Store at room temperature between 68°-77°F (20°-25°C) and do not use if the foil seal is broken or missing.

Packaging Info

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

Packaging configurations for Thera Plus Anti-Itch with Aloe Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Thera Plus Anti-Itch with Aloe Hydrocortisone, 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 SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of 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, poison oak, poison sumac, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. 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.

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, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to 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. 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, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

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

The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Care should be taken to avoid contact with the eyes during use.

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. Additionally, it is 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 during application. It is imperative that patients adhere strictly to the recommended dosage; they should not exceed the directed amount unless specifically instructed by a healthcare provider.

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

In the event of rectal bleeding, patients should be instructed to stop use and seek medical advice immediately. If the product is ingested, it is crucial to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product 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, the 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 recommended not to begin the use of any other hydrocortisone product without first consulting a healthcare provider. In the event of rectal bleeding, patients should seek medical attention immediately.

This product should be kept out of reach of children. If swallowed, it is imperative to seek medical help or contact a Poison Control Center without delay.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Thera Plus Anti-Itch with Aloe Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Thera Plus Anti-Itch with Aloe Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is also recommended to seek medical advice prior to application.

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

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone cream is not associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. As such, healthcare professionals should consider the benefits and risks of hydrocortisone cream use in pregnant patients on a case-by-case basis, taking into account the clinical context and the severity of the condition being treated.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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 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 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 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.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal management and patient safety.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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. It is essential to emphasize that they should not use more of the product than directed unless specifically instructed to do so 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 a tamper-evident container. It is essential to ensure that the foil seal is intact; do not use the product if the seal is broken or missing.

For optimal storage, the product should be kept at room temperature, specifically within the range of 68° to 77°F (20° to 25°C). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Thera Plus Anti-Itch with Aloe 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 Anti-Itch with Aloe 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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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.