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Cortizone 10 Intensive Healing Itch Relief Cream

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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 2025
Label revision date
February 1, 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 2025
Label revision date
February 1, 2025
Manufacturer
Chattem, Inc.
Registration number
M017
NDC root
41167-0023
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Cortizone 10 is an intensive healing itch relief cream designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. It can help soothe discomfort associated with 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 offers relief for external anal and genital itching.

This cream works by targeting the underlying causes of itching, helping to calm your skin and alleviate discomfort. If you have persistent skin issues, it's important to consult with a doctor for further advice and supervision.

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 irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. 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 using it.

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

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 this product if you experience rectal bleeding or if your condition worsens, persists for more than 7 days, or clears up only to return shortly after. Always check with your doctor before starting any other hydrocortisone product.

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

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash, and it's best to consult a doctor in these cases. Be careful to keep the product 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, keep this product out of reach of children, as swallowing it can require immediate medical attention or a call to Poison Control.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product 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. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek 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. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

Pregnancy Use

When it comes to using Cortizone 10 Intensive Healing Itch Relief Cream during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this cream on you or your developing baby have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication or topical treatment. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, you can use Cortizone 10 Intensive Healing Itch Relief Cream without specific warnings or recommendations against it. There are no known concerns about this product being passed into breast milk or posing any risk to your nursing infant.

As always, if you have any questions or concerns about using this cream while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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, you should also consult a doctor if your child is under 12 years of age. 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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 you understand how to manage your treatment effectively while considering your kidney 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 may affect you if you have hepatic impairment (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. 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 of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F) and keep it away from light. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it to ensure safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. If the patient is under 2 years old or if the child is under 12 years old, it's important to consult a doctor before use. For external anal and genital itching, adults can also apply it to the affected area up to 3 to 4 times daily. Always follow your healthcare provider's guidance for safe and effective use.

FAQ

What is Cortizone 10 used for?

Cortizone 10 is an intensive healing itch relief cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

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 using Cortizone 10 and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is Cortizone 10 safe to use during pregnancy or while nursing?

There is no specific information regarding the use of Cortizone 10 during pregnancy or lactation, so consult a doctor for advice.

What should I do if I swallow Cortizone 10?

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

How should I store Cortizone 10?

Store Cortizone 10 at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Cortizone 10 Intensive Healing Itch Relief Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Cortizone 10 is an intensive healing cream formulated for effective itch relief. The product is presented in a cream dosage form, with a net weight of 1 oz (28 g).

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 medication 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 medication should then be applied to the affected area, not exceeding 3 to 4 applications per day. For children under 12 years of age, consultation with a physician is also recommended before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is not recommended for patients with vaginal discharge; consultation with a healthcare professional is advised.

  • This product should not be used for the treatment of diaper rash; consultation with a healthcare professional is necessary.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, discontinue use and consult a doctor. Rectal bleeding also necessitates immediate medical consultation.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the genital area if they are experiencing vaginal discharge; consultation with a physician is recommended in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior medical consultation.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. It is crucial that patients adhere to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed to do so by a healthcare professional. Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated.

Patients should be advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, patients should not initiate the use of any other hydrocortisone product without consulting a physician. In the event of rectal bleeding, patients must stop using the product and consult a healthcare provider immediately.

To ensure safety, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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, this 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 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. It is also crucial to seek medical advice if rectal bleeding occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center 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 Cortizone 10 Intensive Healing Itch Relief Cream (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cortizone 10 Intensive Healing Itch Relief Cream.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 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, it is recommended that children under 12 years of age also seek medical advice before application.

Geriatric Use

There is no specific information available 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

There is no specific information available regarding the use of Cortizone 10 Intensive Healing Itch Relief Cream during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential. It is advisable to consult with a healthcare provider for individualized recommendations.

Lactation

There are no specific warnings or recommendations regarding the use of Cortizone 10 Intensive Healing Itch Relief Cream in lactating mothers. Additionally, there are no statements concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants during the use of this product while nursing.

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 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 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 to prevent accidental ingestion. In the event of swallowing the product, patients 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, it is important to communicate that the product is not intended for the treatment of diaper rash, and a consultation with a doctor is recommended for this condition.

Patients should 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 advised not to begin the use of any other hydrocortisone product without first consulting a doctor. Furthermore, patients should be made aware that they need to stop use and seek medical advice if rectal bleeding occurs.

While using the product, patients should be cautioned to avoid contact with their eyes. It is essential to emphasize that patients should not use more of the product than directed unless specifically instructed to do so by a doctor. Lastly, patients should be informed that the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and must be protected from light exposure. To maintain the quality of the product, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with specific guidelines for different age groups. 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 children under 2 years of age, consultation with a doctor is advised. In cases of external anal and genital itching, adults are also instructed to apply the medication to the affected area no more than 3 to 4 times daily, while children under 12 years of age should seek medical advice before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cortizone 10 Intensive Healing Itch Relief Cream, 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 Intensive Healing Itch Relief Cream, retrieved by a validated AI data-extraction workflow.

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

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

No human clinician has reviewed this version.

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

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

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