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Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Co...

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage forms
  • Cream
  • Gel
  • Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
October 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage forms
  • Cream
  • Gel
  • Ointment
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 2007
Label revision date
October 20, 2025
Manufacturer
Chattem, Inc.
Registration number
M017
NDC roots
41167-0035, 41167-0036, 41167-0039, 41167-0105, 41167-0339
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (16 NDCs)
Packaging & NDC Codes (16)

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

Cortizone-10® is a cooling gel formula that contains 1% hydrocortisone, which is a type of medication used to relieve itching. It works by temporarily alleviating discomfort associated with minor skin irritations, inflammation, and rashes. You can use it for various conditions, including eczema, psoriasis, insect bites, and reactions to plants like poison ivy, oak, and sumac.

This maximum strength gel cools the itch on contact, providing quick relief for external skin irritations. It's important to use this product as directed, and for any other uses, you should consult with a doctor.

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 plants like poison ivy, oak, or sumac. It’s also effective for soothing itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can help relieve external itching in the anal and genital areas. However, 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 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 product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid using more than the recommended amount unless directed by your doctor, and do not insert it directly into the rectum using fingers or any devices.

If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult your doctor. While using this product, be careful to avoid contact with your eyes. Always prioritize your health and seek medical advice when needed.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor. Be careful to keep it away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional.

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

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Do not apply it in the genital area if you have a vaginal discharge or for treating diaper rash; consult your doctor in these cases. While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless directed by your doctor. Additionally, do not insert it directly into the rectum using fingers or any devices.

If your condition worsens, if 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. You should also seek medical advice if you experience rectal bleeding. In case of accidental swallowing, get emergency 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 act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain products. Avoid using this product in the genital area if you have a vaginal discharge, and consult your doctor for guidance. Additionally, do not use it for treating diaper rash without first speaking to your healthcare provider. Always seek medical advice before using this product for any other purposes during your pregnancy to ensure your safety and the well-being 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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 years, you should also check with a doctor if the treatment is for itching in the anal or genital areas.

For children aged 2 years and older, you can apply the medication to the affected area, but make sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 (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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and keep it out of reach of children. It's important to protect the product from light and avoid freezing it, as extreme temperatures can affect its quality. Once opened, please discard the product to maintain safety and prevent any potential contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, apply the medication to the affected area no more than 3 to 4 times daily. If you are treating external anal and genital itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. For children under 2 years old or those under 12 years old, consult a doctor before use.

Remember, this product is for external use only. Avoid using it in the genital area if you have a vaginal discharge, and consult a doctor for diaper rash treatment. Do not let the medication come into contact with your eyes, and do not exceed the recommended dosage unless directed by a doctor. If your condition worsens, persists for more than 7 days, or recurs shortly after clearing up, stop using the product and consult a doctor. Keep it out of reach of children, and seek medical help immediately if swallowed.

FAQ

What is Cortizone-10®?

Cortizone-10® is a cooling gel formula containing 1% hydrocortisone, designed to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes.

What conditions can Cortizone-10® help relieve?

It provides relief for conditions such as eczema, psoriasis, poison ivy, insect bites, and seborrheic dermatitis, among others.

How should I use Cortizone-10®?

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 Cortizone-10®?

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

What should I do if my condition worsens?

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

Is Cortizone-10® safe for nursing mothers?

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

How should I store Cortizone-10®?

Store at room temperature, keep out of reach of children, and protect from light. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus is available in multiple dosage forms and packaging configurations.
Details

Drug Information (PDF)

This file contains official product information for Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

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. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The product 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 physician is recommended before use.

Contraindications

Use of this product 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.

The product should not be used more than directed unless specifically instructed by a physician. Direct application into the rectum using fingers, mechanical devices, or applicators is also contraindicated.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs. Furthermore, patients should avoid contact with the eyes during use.

Warnings and Precautions

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

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. It is also important to 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 resolve and then recur within a few days. Furthermore, users should not 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 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 prior consultation with a healthcare professional.

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 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 their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. It is also recommended not to initiate the use of any other hydrocortisone product without consulting a doctor. In the event of rectal bleeding, patients should stop use and consult a healthcare provider immediately.

In case of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus is available in multiple dosage forms and packaging configurations.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, it is advised to seek medical advice for the treatment of external anal and genital itching.

For adults and children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against using this product in the genital area if they have a vaginal discharge, and they should consult a healthcare professional for guidance. Additionally, this product is not indicated for the treatment of diaper rash, and pregnant patients should seek medical advice before using it for any other purposes. The safety and efficacy of this product during pregnancy have not been established, and its use should be under the advice and supervision of a healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available 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 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 this drug. 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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.

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 not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients must be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be cautioned against using any other hydrocortisone product without first consulting a doctor.

If rectal bleeding occurs, patients should discontinue use and seek medical advice promptly.

While using this product, patients should be advised to avoid contact with their eyes. They should also be instructed not to exceed the recommended dosage unless directed by a healthcare provider. 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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from direct light to maintain its integrity. Additionally, the product must not be frozen, as this could compromise its effectiveness.

To ensure safety, the product should be kept out of reach of children. Once opened, it is important to discard any remaining product to prevent potential misuse or degradation. Proper handling and storage conditions are crucial for maintaining the quality and safety of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended. In cases of external anal and genital itching, adults should clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. Children under 12 years should also seek medical advice before use.

Clinicians should counsel patients that the product is for external use only and should not be applied in the genital area if there is a vaginal discharge. It is important to avoid contact with the eyes and not to exceed the recommended dosage unless directed by a physician. Patients should refrain from inserting the product directly into the rectum and should discontinue use and consult a doctor if symptoms worsen, persist beyond 7 days, or recur shortly after resolution. Additionally, the medication should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

This file contains official product information for Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus, 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 Cortizone 10, Cortizone 10 Cooling Relief, Cortizone 10 Intensive Healing, Cortizone 10 Plus, 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

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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.