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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
September 29, 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
September 29, 2024
Manufacturer
Topco Associates LLC
Registration number
M017
NDC root
36800-981
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 caused by minor skin conditions. This cream is enriched with healing moisturizers and vitamins A, D, and E, which help soothe and nourish the skin. It works by temporarily relieving itching associated with various skin irritations, including eczema, psoriasis, and reactions to poison ivy, oak, and sumac.

In addition to its anti-itch properties, Hydrocortisone 1% Cream is formulated to address inflammation and redness, making it a maximum strength option for those seeking quick relief. It is important to use this cream as directed, and for any other uses, you should consult with a healthcare professional.

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.

In addition to skin irritations, this product can temporarily relieve itching in the external anal and genital areas. For any other uses, it's important 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 important to consult a doctor before using this medication.

For external itching in the anal and genital areas, adults should 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. 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

You should avoid using this product in the genital area if you have a vaginal discharge; it's important to consult a doctor in such cases. Additionally, do not use it for treating diaper rash without medical advice. Always keep the product away from your eyes, and follow the usage instructions carefully—do not exceed the recommended amount unless directed by a healthcare professional. Lastly, never insert the product directly into the rectum using your fingers or any device. If you have any questions or concerns, please reach out to your doctor for guidance.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. 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, keep this product out of reach of children, as swallowing it can require immediate medical attention.

Please do not use this product in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. Remember, this product is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Specifically, do not apply it in the genital area if you have a vaginal discharge, and do not use it for diaper rash without consulting a doctor first.

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

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

It is important to avoid using this medication if you are pregnant, as its safety during pregnancy has not been established. If you are currently pregnant or planning to become pregnant, it is crucial to consult your doctor before using this medication. Your healthcare provider can help you understand the potential risks and make informed decisions about your health and the health of your baby.

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. Additionally, there are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without special concerns about its effects on your milk production or your baby's health. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 this 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. Children under 12 years old should also consult a doctor before use. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the integrity of the device.

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 of any components.

Additional Information

No further information is available.

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 external anal and genital itching, clean the area first and then apply.

Are there any precautions I should take when using this cream?

Avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. If you have a vaginal discharge or are treating diaper rash, consult a doctor.

What should I do if my condition worsens or does not improve?

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 Hydrocortisone 1% Cream during pregnancy?

Safety during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

What are the side effects of Hydrocortisone 1% Cream?

For external use only, and if swallowed, seek medical help immediately. Common side effects may include skin irritation, but consult a doctor for any severe reactions.

Can children use Hydrocortisone 1% Cream?

Children under 2 years of age should not use this cream without consulting a doctor. For children under 12 years, consult a doctor for external anal and genital itching.

How should I store Hydrocortisone 1% Cream?

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

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

Hydrocortisone 1% Cream is a topical formulation designed for the relief of skin irritation, inflammation, and redness. This cream is enriched with a blend of ten moisturizers, including healing moisturizers, and is fortified with vitamins A, D, and E. It is classified as a maximum strength anti-itch cream, providing fast relief for various skin conditions. The product is packaged in a net weight of 1 ounce (28 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, the use of this product is not recommended; consultation with a physician is advised.

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 product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor should be consulted for appropriate alternatives.

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

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it is not recommended for the treatment of diaper rash without prior consultation with a healthcare provider.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then 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. Furthermore, if rectal bleeding occurs, immediate medical consultation is advised.

In the event of accidental ingestion, patients should seek emergency 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 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 medical guidance.

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. The product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, patients should seek medical attention if rectal bleeding occurs.

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.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. 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 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, the product should not be used without consulting a doctor.

In cases of external anal and genital itching, adults are advised to clean the affected area with mild soap and warm water, rinsing thoroughly, and then gently drying the area by patting or blotting with toilet tissue or a soft cloth before application. The same frequency of application, not more than 3 to 4 times daily, applies. For children under 12 years of age, it is recommended to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The use of this medication is contraindicated in pregnant patients. Safety during pregnancy has not been established, and there is insufficient data to assess the potential risks to fetal outcomes. Women of childbearing potential should consult a healthcare professional before using this medication if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical guidance are vital in managing cases of overdosage effectively.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash without first consulting a healthcare professional.

Patients must be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms clear up and then recur within a few days. It is crucial to inform patients not to begin the use of any other hydrocortisone product without prior consultation with a healthcare provider.

Healthcare providers should emphasize that patients need to stop using the product and seek medical attention if rectal bleeding occurs. While using the product, patients should be reminded to avoid contact with the eyes and to adhere strictly to the directed dosage. They should not exceed the recommended amount unless specifically instructed by a doctor. Furthermore, patients should be cautioned against inserting 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°-25°C (68°-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

No further data are available.

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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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.