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Theracare Maximum Strength 1% Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 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 2021
Label revision date
December 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2021
Label revision date
December 18, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-211
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

TheraCare Maximum Strength 1% Hydrocortisone Cream is a topical medication designed to temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. You may find it helpful for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It can also soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis, as well as provide temporary relief for external anal and genital itching.

This cream works by reducing inflammation and calming the skin, helping to alleviate discomfort. However, it's important to use this product under the advice and supervision of a doctor for any other uses beyond its primary purpose.

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 such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can relieve external anal and genital itching.

For any other uses, it's important to consult with your doctor for guidance 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. This is suitable for adults and children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a physician before use.

For external itching in the anal and genital areas, adults and children aged 12 and older should first clean the area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If your child is under 12 years old, please consult a physician for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it to the genital area if you have a vaginal discharge, as this could lead to complications. Additionally, avoid using it for treating diaper rash, and do not combine it with any other hydrocortisone products unless you have consulted with your doctor first. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

When using this product, it's important to follow the directions carefully. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash. Additionally, do not combine it with other hydrocortisone products unless advised by a doctor. If you experience worsening symptoms, if your condition does not improve after 7 days, or if you notice rectal bleeding, stop using the product and consult a doctor.

If the product is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Remember to keep it away from your eyes and do not use more than directed unless instructed by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas, especially if you have a vaginal discharge. It should not be used for diaper rash or in combination with other hydrocortisone products unless directed by your doctor.

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, seek medical advice immediately.

In case of accidental swallowing, it’s important to get emergency medical help right away or contact a Poison Control Center 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 may include unusual symptoms, but specific details on 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 considering the use of TheraCare Maximum Strength 1% Hydrocortisone Cream during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical treatments like this cream. They can provide personalized advice based on your health needs and circumstances.

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 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 physician (doctor) before using the product.

For external anal and genital itching, the treatment is suitable for children aged 12 years and older, with the same application frequency of 3 to 4 times daily. If your child is younger than 12, please consult a physician for guidance. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of TheraCare Maximum Strength 1% Hydrocortisone Cream in older adults, it's always important to approach any new treatment with caution. If you or a loved one is considering using this cream, it’s wise to consult with a healthcare provider first. They can help determine if this product is appropriate for your needs and discuss any potential safety concerns or precautions that may be relevant for older adults.

Since the drug insert does not mention any dosage adjustments or special precautions for elderly patients, your healthcare provider can guide you on the best practices for using this cream safely and effectively. Always prioritize open communication with your healthcare team to ensure the best outcomes for your health.

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 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 monitor your kidney function 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 should be used if you have hepatic impairment (issues with liver function).

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 be cautious when using hydrocortisone. You should not use it alongside any other hydrocortisone products unless you have consulted with your doctor. This is crucial because combining these medications can lead to unwanted side effects or complications.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance tailored to your specific health needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness and safety. It's also important to check the tube seal under the cap before use; if the seal is broken, do not use the product, as this could compromise its integrity and safety.

When handling the product, always do so with care to avoid any damage. 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 postmarketing experiences related to this medication. If you have any questions about how to use it or its effects, be sure to consult your healthcare provider.

FAQ

What is TheraCare Maximum Strength 1% Hydrocortisone Cream used for?

TheraCare Maximum Strength 1% Hydrocortisone Cream temporarily relieves itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this cream help relieve itching from?

It can relieve itching due to eczema, psoriasis, poison ivy, insect bites, detergents, jewelry, cosmetics, soaps, seborrheic dermatitis, and external anal and genital itching.

How should I use this cream?

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 physician.

Are there any warnings I should be aware of?

This cream is for external use only. Avoid contact with eyes and do not use more than directed unless advised by 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.

Can I use this cream for diaper rash?

No, do not use this cream for the treatment of diaper rash.

What should I do if I accidentally swallow the cream?

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is there any specific information regarding use during pregnancy or nursing?

There is no specific information regarding the use of this cream during pregnancy or nursing in the provided text.

How should I store TheraCare Maximum Strength 1% Hydrocortisone Cream?

Store the cream at 20-25°C (68-77°F) and do not use it if the tube seal under the cap is broken.

Packaging Info

Below are the non-prescription pack sizes of Theracare Maximum Strength 1% Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare Maximum Strength 1% Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Theracare Maximum Strength 1% Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

TheraCare Maximum Strength 1% Hydrocortisone Cream contains hydrocortisone as the active ingredient at a concentration of 1%. This formulation is presented in a cream dosage form, designed for topical application. The product is available in both a tube and a pack for convenience. Visual references for the packaging and labeling include the pack image (92-19020 0321 PKG hydrocortisone cream.jpg) and the label image (92-19019 0321 TUBE hydrocortisone.jpg).

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 only be undertaken 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 following dosing guidelines are recommended:

Adults and children aged 2 years and older should 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, adults and children aged 12 years and older 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. 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 recommended before application.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in patients with a vaginal discharge due to the potential for exacerbating the condition. It is also contraindicated for the treatment of diaper rash, as this may lead to adverse effects. Additionally, concurrent use with any other hydrocortisone product is not recommended unless directed by a healthcare professional, to avoid the risk of excessive corticosteroid exposure.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area if there is a vaginal discharge present. It should not be used for the treatment of diaper rash. Additionally, the concurrent use of this product with any other hydrocortisone product is not recommended unless directed by a healthcare professional.

Healthcare professionals should advise patients 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. Patients should also be instructed not to initiate the use of any other hydrocortisone product without consulting a doctor. Immediate medical attention is required if rectal bleeding occurs.

In cases of accidental ingestion, it is imperative to seek 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, for the treatment of diaper rash, and should not be used in conjunction with any other hydrocortisone product unless directed by a healthcare professional.

While using this product, patients are advised to follow the instructions carefully. It is important to avoid contact with the eyes and not to exceed the recommended dosage unless specifically instructed by a doctor. Additionally, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should 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. Rectal bleeding is another critical reason to stop use and seek medical advice.

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

Drug Interactions

Co-administration of this product with other hydrocortisone formulations is contraindicated unless specifically directed by a healthcare professional. The use of multiple hydrocortisone products may increase the risk of systemic side effects and potential overdose. It is essential for healthcare providers to evaluate the necessity of concurrent use and to monitor patients closely for any adverse effects if such combinations are deemed necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Maximum Strength 1% Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare Maximum Strength 1% Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for itching associated with skin irritation, inflammation, and rashes by applying it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

For external anal and genital itching, the medication is indicated for adults and children 12 years of age and older, with the same application frequency of 3 to 4 times daily. Children under 12 years of age should also consult a physician before use.

Geriatric Use

There is no specific information regarding the use of TheraCare Maximum Strength 1% Hydrocortisone Cream in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is recommended, as elderly patients may have different pharmacokinetic and pharmacodynamic responses compared to younger individuals.

Pregnancy

There is no specific information available regarding the use of TheraCare Maximum Strength 1% Hydrocortisone Cream during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when making treatment decisions for pregnant patients.

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 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on the appropriate steps to take.

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 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to use the medication only as directed and to avoid contact with the eyes. It is important to emphasize that patients should not exceed the recommended dosage unless specifically instructed to do so by a healthcare professional. Additionally, patients should be cautioned against inserting the medication directly into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format. It should be stored at a temperature range of 20-25°C (68-77°F). It is imperative that the product is not used if the tube seal under the cap is broken, as this may compromise the integrity of the product.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Theracare Maximum Strength 1% 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 Theracare Maximum Strength 1% 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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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.