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Theracare Hydrocortisone Cream

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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 2023
Label revision date
May 21, 2024
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 2023
Label revision date
May 21, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-220
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 Hydrocortisone Cream is a topical medication designed to temporarily relieve itching caused by 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, making it easier for you to manage discomfort from various skin issues. However, it's important to use this product under the advice and supervision of a doctor for any other uses.

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, 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 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 who are 2 years old and older. However, if your child is under 2 years of age, 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 in the genital area if you have a vaginal discharge, and it is not intended for treating diaper rash. Additionally, avoid using it alongside any other hydrocortisone products unless you have consulted with your doctor first.

Never insert this medication directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of your treatment.

Side Effects

You should be aware that this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash. It's important to follow the directions carefully and avoid contact with your eyes. Do not use more than the recommended amount unless directed by a doctor, and do not insert it into the rectum using fingers or any device.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice. If the product is swallowed, contact a Poison Control Center or seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on the genital area if you have a vaginal discharge or for treating diaper rash. It's important to use this medication exactly as directed and not to combine it with any other hydrocortisone product unless you have consulted your doctor. Be careful to keep it away from your eyes and do not apply it 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, you should also stop use and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Your safety is the top priority, so acting quickly can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings, precautions, or dosage changes related to the use of TheraCare Hydrocortisone Cream mentioned in the available information. This means that, based on the current data, it is considered safe to use as directed during pregnancy. However, always consult with your healthcare provider before starting any new medication or treatment to ensure it is appropriate for your individual situation.

Lactation Use

If you are a nursing mother, you can use TheraCare Hydrocortisone Cream without specific warnings or precautions. Currently, there is no information available about whether this cream is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using medications while breastfeeding. They can provide personalized advice based on your situation.

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 Hydrocortisone Cream in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual needs.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when using hydrocortisone products. You should avoid using this medication alongside any other hydrocortisone products unless you have consulted with your doctor. This is crucial to prevent potential complications or side effects.

Always discuss any medications you are taking with your healthcare provider, as they can help you understand how different drugs may interact and ensure your treatment is safe and effective. If you have any questions about your medications or lab tests, don't hesitate to reach out to your healthcare team for guidance.

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. Always check the tube seal under the cap before use; if it is broken, do not use the product, as this could compromise its integrity and safety.

Handling the product with care is essential. Make sure to keep it in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This guideline applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, the same frequency applies, but it is specifically for adults and children aged 12 years and older. Always follow the instructions provided by your healthcare provider for the best results.

FAQ

What is TheraCare Hydrocortisone Cream used for?

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

What conditions can TheraCare Hydrocortisone Cream help with?

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 TheraCare Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, adults and children 12 years and older should also apply 3 to 4 times daily.

Are there any contraindications for using TheraCare Hydrocortisone Cream?

Do not use it in the genital area if you have a vaginal discharge, for diaper rash, or with any other hydrocortisone product unless advised by a doctor.

What should I do if I experience side effects?

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

Is TheraCare Hydrocortisone Cream safe to use during pregnancy or while nursing?

There are no specific pregnancy-related warnings or precautions mentioned, and no information is provided regarding its use in nursing mothers.

What should I do if I accidentally swallow TheraCare Hydrocortisone Cream?

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

How should I store TheraCare Hydrocortisone Cream?

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

Packaging Info

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

Packaging configurations for Theracare Hydrocortisone Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TheraCare Hydrocortisone Cream is a topical formulation designed for the management of inflammatory skin conditions. The active ingredient is hydrocortisone, a synthetic corticosteroid known for its anti-inflammatory properties. The cream is presented in a convenient dosage form suitable for application to affected areas of the skin.

The formulation is characterized by its creamy texture, which facilitates easy application and absorption. It is intended for use in various dermatological conditions where corticosteroid therapy is indicated. The effective time for this product is noted as July 1, 2023.

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 of this product is contraindicated in the following situations:

The product should not be applied to the genital area in patients with vaginal discharge due to the potential for exacerbating underlying conditions. It is also contraindicated for the treatment of diaper rash, as the safety and efficacy in this context have not been established. Additionally, concurrent use with any other hydrocortisone product is not recommended unless directed by a healthcare professional, to avoid the risk of systemic absorption and potential side effects. Furthermore, the product should not be administered directly into the rectum using fingers or any mechanical device or applicator, as this may lead to complications or irritation.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area, particularly in the presence of vaginal discharge. It is also not indicated for the treatment of diaper rash. Healthcare professionals should advise patients against using this product in conjunction with any other hydrocortisone formulations unless specifically directed by a physician.

Patients must adhere strictly to the recommended usage guidelines. Contact with the eyes should be avoided to prevent irritation. The product should not be applied in excess of the directed dosage unless instructed by a healthcare provider. Additionally, it is imperative that the product is not administered directly into the rectum using fingers, mechanical devices, or applicators.

Patients should be instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. The use of any other hydrocortisone product should not commence without prior consultation with a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek 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, or 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, avoiding contact with the eyes and not exceeding the recommended dosage unless specifically instructed by a doctor. It is important to refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients should discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if rectal bleeding occurs, medical advice should be sought immediately.

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

The concurrent use of this medication with any other hydrocortisone product is contraindicated unless specifically directed by a healthcare professional. This precaution is essential to avoid potential additive effects that could lead to increased risk of adverse reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not necessary unless otherwise indicated by clinical circumstances.

Packaging & NDC

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

Packaging configurations for Theracare Hydrocortisone Cream.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not 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 product is indicated for adults and children 12 years of age and older, with the same application frequency of not more than 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 Hydrocortisone Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

TheraCare Hydrocortisone Cream does not have specific pregnancy-related warnings, precautions, or dosage modifications indicated in the available prescribing information. As with any medication, healthcare professionals should consider the potential benefits and risks when prescribing this product to pregnant patients. It is advisable to assess the necessity of treatment and to use the lowest effective dose for the shortest duration necessary. Given the lack of specific data, further studies may be warranted to fully understand the implications of TheraCare Hydrocortisone Cream use during pregnancy.

Lactation

There are no specific warnings or precautions regarding the use of TheraCare Hydrocortisone Cream in lactating mothers. Additionally, there is no information available about the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

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, although specific recommendations are not outlined.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 directed 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 product is administered topically, with a recommended application frequency of 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, the same frequency applies specifically to adults and children aged 12 years and older. 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 Theracare Hydrocortisone Cream, 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 Hydrocortisone Cream, 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.