Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Topcare

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 1995
Label revision date
November 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 1995
Label revision date
November 5, 2024
Manufacturer
Topco Associates LLC
Registration number
M017
NDC root
36800-059
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 Cream 1% is an antipruritic (anti-itch) cream that contains Aloe and is designed to provide temporary relief from itching caused by minor skin irritations and rashes. This cream is commonly used to treat various conditions, including eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

When applied to the affected area, Hydrocortisone Cream works to soothe discomfort and reduce itching, helping you feel more comfortable in your skin. It's important to use this product as directed and consult with a doctor for any other uses.

Uses

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

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. For those dealing with external anal itching, it's important to first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if your child is under 12 years of age, it's best to check with a doctor before use to ensure safety and proper guidance.

What to Avoid

You should avoid using this product in your eyes or inserting it into the rectum using fingers or any devices. If your condition worsens, lasts more than seven days, or clears up only to return within a few days, stop using the product and consult a doctor. It's important not to start any other hydrocortisone product without medical advice.

While using this product, please consult your doctor if you feel the need to exceed the recommended dosage. This ensures your safety and helps prevent potential misuse or dependence (a reliance on a substance).

Side Effects

You should be aware that this product is for external use only and should not be applied in or around the eyes, nor should it be inserted into the rectum using fingers or any devices. Before using this product, consult a doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, if the product is swallowed, it’s important to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or inserting it into the rectum with fingers or any devices. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage and consult your doctor if you feel the need to exceed it. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. Avoid starting any other hydrocortisone product without consulting a healthcare professional first.

Keep this product out of reach of children. If swallowed, seek medical 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 1% with Aloe 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 whether it is safe to use during pregnancy.

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

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that, based on the available information, it is considered safe for you to use without concerns about affecting your milk production or your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old and experiencing external anal itching, it's best to consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of TopCare Hydrocortisone 1% with Aloe in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

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 determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

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 known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective, tailored specifically to your health needs. Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your health and safety are the top priority.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. This helps maintain its effectiveness. Additionally, you should check the carton or tube crimp for important information such as the lot number and expiration date, which are essential for tracking and ensuring the product is still safe to use.

Always handle the product with care, and make sure to follow any specific instructions provided for its use. Proper storage and attention to these details will help you use the product safely and effectively.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If you are dealing with external anal itching, it's recommended to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is used for temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I apply 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 itching, cleanse the area with mild soap and warm water before application.

Are there any age restrictions for using this cream?

Do not use Hydrocortisone Cream in children under 2 years of age. Consult a doctor for children under 12 years of age.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition gets worse, persists for more than 7 days, or clears up and occurs again within a few days.

Can I use this cream for vaginal discharge or rectal bleeding?

You should ask a doctor before using this product if you have a vaginal discharge or rectal bleeding.

Is there any specific advice for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What should I do if I accidentally swallow the cream?

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

Where should I store Hydrocortisone Cream?

Store the cream at room temperature and check the carton or tube crimp for the lot number and expiration date.

Are there any teratogenic effects associated with this cream?

No teratogenic effects are mentioned for Hydrocortisone Cream 1%.

Can I use this cream in my eyes?

No, do not use Hydrocortisone Cream in the eyes or insert it into the rectum using fingers or any device.

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 Cream 1% is a topical formulation indicated for the relief of itching associated with minor skin irritations, inflammation, and rashes. This maximum strength cream contains hydrocortisone as the active ingredient, providing antipruritic properties. The formulation is enhanced with aloe to soothe the skin. Each tube contains a net weight of 1 ounce (28.4 grams). The product is identified by the National Drug Code (NDC) 36800-059-02 and is marketed under the TopCare® health™ brand.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis, and external genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For the treatment of external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

The use of this product is not recommended for children under 2 years of age; consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the eyes and for rectal administration via fingers, mechanical devices, or applicators.

If the condition worsens, persists for more than 7 days, or resolves and recurs within a few days, discontinue use and consult a healthcare professional. The use of any other hydrocortisone product should not be initiated without prior consultation with a doctor.

Additionally, it is advised to consult a healthcare professional before exceeding the recommended dosage.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Prior to use, individuals should consult a healthcare professional if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

While using this product, it is crucial to adhere to the recommended dosage. Consultation with a healthcare provider is advised before exceeding the recommended dosage to avoid potential complications.

Users should discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than 7 days, or resolves only to recur within a few days. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Before using this product, patients are advised to consult a healthcare professional if they experience vaginal discharge, rectal bleeding, or diaper rash.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

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

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

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 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, and a consultation with a healthcare professional is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is important to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of TopCare Hydrocortisone 1% with Aloe in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that may be necessary 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 potential adverse effects and evaluating the overall treatment plan may be prudent to ensure the safety and efficacy of therapy in elderly individuals.

Pregnancy

There are no specific statements regarding the use of TopCare Hydrocortisone 1% with Aloe during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks and benefits of using this medication in pregnant patients should be carefully considered. Healthcare professionals are advised to evaluate the necessity of treatment and to discuss any concerns with women of childbearing potential. Given the lack of data, caution is recommended when prescribing this medication to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific warnings or recommendations related to lactation in the provided information. Therefore, healthcare professionals may consider the absence of contraindications when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 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 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 these contexts.

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

Patients should be informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or resolves only to recur within a few days. Patients should be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be advised to consult a doctor before exceeding the recommended dosage. Additionally, patients should be encouraged to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature 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

For patients aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching, it is recommended that adults cleanse 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.

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 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.

Learn more in our Editorial Policy

Last AI update:

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.