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Topcare

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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 1995
Label revision date
July 15, 2025
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 1995
Label revision date
July 15, 2025
Manufacturer
Topco Associates LLC
Registration number
M017
NDC root
36800-099
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 an antipruritic (anti-itch) cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as insect bites and irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help relieve external anal and genital itching.

This cream works by reducing inflammation and soothing the skin, making it a helpful option for managing discomfort associated with various skin issues. However, for other uses, it is important to consult with a doctor for proper guidance.

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 also helps soothe itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to skin irritations, this product can temporarily relieve itching in external anal and genital areas. If you have other uses in mind, it's best 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 use.

For external itching around the anal and genital areas, adults should first clean the area gently with mild soap and warm water, making sure to rinse thoroughly. After cleaning, 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 under 12 years old, please consult a doctor 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 or use it for diaper rash without consulting a doctor. Additionally, avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

If you have any questions or concerns about using this medication, please reach out to your doctor for guidance. Your health and safety are the top priority.

Side Effects

You should only use this product externally and avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult a doctor in these cases. While using the product, be careful to keep it away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. It’s important not to insert the product into the rectum using fingers or any devices.

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

Warnings and Precautions

This product is for external use only, so please avoid using it on internal areas, especially if you have a vaginal discharge or diaper rash—consult your doctor in these cases. When applying, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using fingers or any devices.

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

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

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. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

When considering the use of TopCare Hydrocortisone Intensive Healing Formula during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how this product may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including over-the-counter products like this one. They can help you weigh the potential risks and benefits based on your individual health needs.

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 doctor before using the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance. Always prioritize your child's safety and well-being by seeking professional advice when needed.

Geriatric Use

When considering the use of TopCare Hydrocortisone Intensive Healing Formula for older adults, it's important to note that the drug insert does not provide specific information about how this product may affect elderly patients. This means there are no special dosage adjustments, safety concerns, or precautions outlined for older individuals.

As a caregiver or an older adult, you should always consult with a healthcare professional before starting any new treatment. They can help determine if this product is appropriate for your needs and ensure that it is used safely.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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 lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness. Always check the carton or tube crimp for the lot number and expiration date to ensure you are using a safe and effective product.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and handling are essential for your safety and the product's reliability.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is Hydrocortisone 1% Cream used for?

Hydrocortisone 1% Cream is an antipruritic cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including 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.

Are there any warnings when using this cream?

Yes, avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use this cream for diaper rash?

No, do not use Hydrocortisone 1% Cream for the treatment of diaper rash; consult a doctor instead.

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.

Is it safe to use during pregnancy?

There are no specific statements regarding the use of Hydrocortisone 1% Cream during pregnancy in the provided information.

What should I do if I accidentally swallow the cream?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Can I use this cream for external anal and genital itching?

Yes, it temporarily relieves external anal and genital itching, but you should clean the area first and consult a doctor for children under 12.

What conditions should I consult a doctor about before using this cream?

Consult a doctor if you have a vaginal discharge or if you are considering using it for children under 2 years of age.

Packaging Info

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

Packaging configurations for Topcare.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% Cream is an antipruritic formulation designed to alleviate itching and discomfort associated with various skin conditions. This cream features an intensive healing formula, providing targeted relief. The product is packaged in a net weight of 1 ounce (28.4 grams).

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 recommended dosage for adults and children aged 2 years and older is to apply the product 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 product 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 the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised. It is also not recommended for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and 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.

Users must discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. It is essential not to initiate the use of any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is 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.

During the use of 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 seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also crucial to stop use and consult a doctor if rectal bleeding occurs.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Topcare (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication 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 doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. This medication should also be applied to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is recommended to seek a doctor's advice before use.

Geriatric Use

There is no specific information regarding the use of TopCare Hydrocortisone Intensive Healing Formula in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this population.

Pregnancy

There are no specific statements regarding the use of TopCare Hydrocortisone Intensive Healing Formula during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women who are pregnant or may become pregnant, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any potential risks when recommending this product to pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

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

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, they should not use the product for the treatment of diaper rash without first consulting a healthcare professional.

It is important to counsel patients to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised not to begin the use of any other hydrocortisone product unless directed by a doctor.

Healthcare providers should inform patients to stop using the product and consult a doctor if rectal bleeding occurs. While using this product, patients should be cautioned to avoid contact with their eyes.

Patients must be instructed not to exceed the recommended dosage unless advised by a healthcare professional. Furthermore, they should be informed 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 packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

The route of administration for the medication 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 Topcare, 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, 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.