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Topcare Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
October 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2020
Label revision date
October 3, 2024
Manufacturer
Topco Associates LLC
Registration number
M017
NDC root
36800-939
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

Hydrocortisone 1% Cream is a topical medication designed to provide relief from itching and irritation associated with minor skin issues. It works by temporarily alleviating discomfort caused by conditions such as eczema, psoriasis, and rashes from poison ivy, insect bites, and other irritants. This cream also helps soothe external anal and genital itching.

In addition to its active ingredient, Hydrocortisone, this cream is enriched with healing moisturizers and vitamins A, C, and E, along with antioxidants and chamomile, to support skin health. It is a maximum strength formula that can be compared to other over-the-counter options like Cortizone-10.

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 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 adults experiencing itching in the external anal or genital area, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat or blot 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 your child 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 for treating diaper rash or in the genital area if you have a vaginal discharge—please consult your doctor in these cases. Additionally, avoid using this product if you experience rectal bleeding or if your condition worsens, persists for more than seven days, or clears up only to return shortly after. Always ask your doctor before starting any other hydrocortisone product.

While using this medication, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your doctor. Never insert the product directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. 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 for diaper rash or in the genital area if you have a vaginal discharge without first asking a doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the directions provided and do not use more than recommended unless directed by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid using it on areas like diaper rashes or the genital area if you have a vaginal discharge—consult your doctor in these cases.

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 talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Keep this product out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone cream during this time. The information available does not indicate any contraindications (situations where the cream should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication, including hydrocortisone cream, to ensure it is safe for your specific situation.

Lactation Use

You can use hydrocortisone cream while breastfeeding without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or any risks to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about its use while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know the age guidelines. For children under 12 years old, you should consult with a doctor before use. Additionally, if your child is under 2 years old, do not use this medication without first speaking to a doctor. Always prioritize your child's safety by seeking professional advice when it comes to their health.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or recommendations regarding age-related dosage adjustments or safety concerns. This means that, while the medication can be prescribed to older patients, healthcare providers may not have tailored advice for managing its use in this age group.

As always, it’s important for you or your caregiver to discuss any concerns with your healthcare provider, especially if you have other health conditions or are taking multiple medications. Your doctor can help ensure that the treatment is safe and effective 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 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 may affect you if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, 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 a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You can use this medication for treating affected areas by applying it no more than 3 to 4 times daily. If you are an adult or a child aged 2 years and older, apply it directly to the area that needs treatment. For children under 2 years of age, it's important to consult a doctor before use. If you're dealing with external anal and genital itching, it's recommended to first clean the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting with toilet tissue or a soft cloth before applying the medication.

FAQ

What is Hydrocortisone 1% Cream used for?

Hydrocortisone 1% Cream is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone 1% 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 doctor before use.

Are there any contraindications for using this cream?

Do not use Hydrocortisone 1% Cream for diaper rash or in the genital area if you have a vaginal discharge without consulting a doctor.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Can I use this cream during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Hydrocortisone 1% Cream during pregnancy or lactation, so consult your doctor for advice.

What are the side effects of Hydrocortisone 1% Cream?

Common side effects may include skin irritation. If you experience any severe reactions, stop use and seek medical attention.

How should I store Hydrocortisone 1% Cream?

Store the cream at 20°-25°C (68°-77°F) to maintain its effectiveness.

What should I avoid while using this cream?

Avoid contact with the eyes and do not use more than directed unless advised by a doctor.

Packaging Info

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

Packaging configurations for Topcare Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is a maximum strength anti-itch cream formulated with hydrocortisone 1% as the active ingredient. It is designed for the relief of itching and rashes, featuring an intensive healing formula that includes healing moisturizers enriched with vitamins A, C, and E. The cream also contains antioxidants and chamomile to enhance its soothing properties. The product is packaged in a net weight of 1 ounce (28 grams) and is marketed under the TopCare health brand, comparable to Cortizone-10.

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, and sumac exposure, insect bites, reactions to detergents, jewelry, cosmetics, and soaps, as well as 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 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; healthcare professionals should be consulted.

In cases of external anal and genital itching in adults, it is advisable 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 prior to application. The medication should be applied to the affected area no more than 3 to 4 times daily.

For children under 12 years of age, consultation with a healthcare professional is recommended before use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a healthcare professional should be consulted.

Use of this product is also contraindicated in patients experiencing rectal bleeding. If the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, discontinue use and seek medical advice before using any other hydrocortisone product.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate alternatives. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a consultation with a healthcare provider is recommended.

Patients should be instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. It is important to note that patients should not initiate the use of any other hydrocortisone product without first consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, 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 the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

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 healthcare professional. Additionally, 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 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. Furthermore, if rectal bleeding occurs, medical advice should be sought immediately.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Topcare Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For infants and children under 2 years of age, the product is contraindicated and should not be used without medical advice.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of hydrocortisone cream in pregnant patients. Additionally, there are no dosage modifications recommended for individuals who are pregnant. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, the prescribing information does not provide statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the absence of documented concerns.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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 be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers assess the situation thoroughly and initiate appropriate management procedures based on the severity of symptoms presented.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. For patients using the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use.

Patients should be informed to consult a doctor if they experience vaginal discharge while using the product in the genital area. Additionally, healthcare providers should instruct patients to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. Patients should also be cautioned against using any other hydrocortisone products without prior consultation with a healthcare professional.

In the event of rectal bleeding, patients must be advised to stop using the product and consult a doctor. It is essential to remind patients to avoid contact with the eyes while using this product. Furthermore, healthcare providers should emphasize the importance of not exceeding the recommended dosage unless directed by a physician. Patients should also be instructed not to insert 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 for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied 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 doctor before use. In cases of external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

Drug Information (PDF)

This file contains official product information for Topcare 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 Topcare Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.