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Cortizone 10 Itch Relief Massaging Rollerball

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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 2023
Label revision date
May 1, 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 2023
Label revision date
May 1, 2024
Manufacturer
Chattem, Inc.
Registration number
M017
NDC root
41167-0338
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

Cortizone 10 is a topical medication designed to provide temporary relief from itching caused by 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.

This product comes in a convenient massaging rollerball format, making it easy to apply directly to the affected area. While it is effective for these common skin issues, it's important to 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, inflammation, and rashes. You can use it for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It can also help soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

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. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to be cautious when using this product. You should not use it for treating diaper rash; instead, consult your doctor for appropriate advice. If you are allergic to any ingredient in this product, do not use it. Additionally, avoid using this or any hydrocortisone product if your symptoms last longer than 7 days or if they clear up and then return shortly after.

Make sure to keep the product away from your eyes, and do not exceed the recommended dosage unless your doctor advises you to do so. Being mindful of these guidelines can help ensure your safety and well-being.

Side Effects

When using this product, it's important to be aware of potential side effects. You should avoid using it if you are allergic to any of its ingredients or for treating diaper rash—consult a doctor in these cases. While using the product, take care to keep it away from your eyes and follow the usage instructions closely.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult a doctor. Additionally, keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to areas like diaper rash. If you have any allergies to the ingredients, do not use it. While using this product, be careful to keep it away from your eyes and follow the directions closely—do not use more than recommended unless your doctor advises otherwise.

If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and consult your doctor. It's important to keep this product out of reach of children. If a child accidentally swallows it, 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 Cortizone 10 Itch Relief Massaging Rollerball (hydrocortisone cream) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you or your developing baby are not well understood.

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

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 known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

When using this medication 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, it’s important not to use this medication without consulting a doctor first. Always prioritize your child's safety and seek professional advice if you have any questions or concerns.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it’s important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Cortizone 10 used for?

Cortizone 10 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 use Cortizone 10?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. Do not use on children under 2 years of age without consulting a doctor.

Are there any contraindications for using Cortizone 10?

Do not use Cortizone 10 for the treatment of diaper rash or if you are allergic to any ingredient in this product.

What should I do if my condition worsens?

Stop using Cortizone 10 and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use Cortizone 10 if I am pregnant or nursing?

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

What precautions should I take when using Cortizone 10?

Avoid contact with the eyes and do not use more than directed unless advised by a doctor.

How should I store Cortizone 10?

Store Cortizone 10 at room temperature, protect it from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Cortizone 10 Itch Relief Massaging Rollerball.
Details

Drug Information (PDF)

This file contains official product information for Cortizone 10 Itch Relief Massaging Rollerball, 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 specified 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, and reactions to detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended for the treatment of diaper rash; consultation with a healthcare professional is advised. The product should not be used in individuals with a known allergy to any of its ingredients. Additionally, the use of this or any hydrocortisone product is contraindicated if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days, unless directed by a physician. Contact with the eyes should be avoided. Furthermore, the product should not be used in excess of the recommended dosage unless specifically instructed by a healthcare provider.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Individuals with known allergies to any ingredient in this formulation should refrain from use.

During application, 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.

In the event that the condition worsens, or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, the user must discontinue use and seek advice from a healthcare professional before using this or any other hydrocortisone product.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and individuals should consult a doctor if they have any allergies to the ingredients in this formulation.

During the use of this product, patients are advised to avoid contact with the eyes and to adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a healthcare professional.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. In such cases, it is recommended to consult a doctor before using this or any other hydrocortisone product.

Additionally, 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 is advised.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Itch Relief Massaging Rollerball (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cortizone 10 Itch Relief Massaging Rollerball.
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; healthcare professionals should be consulted for guidance.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Cortizone 10 Itch Relief Massaging Rollerball (hydrocortisone cream) during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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 during the use of this product.

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 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for CORTIZONE 10 ITCH RELIEF MASSAGING ROLLERBALL (hydrocortisone cream). As such, there are no additional adverse events or rare case reports to report from voluntary or surveillance programs.

Patient Counseling

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

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. It is essential to caution patients against using the product if they have a known allergy to any of its ingredients.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if the patient's condition worsens or if symptoms persist for more than 7 days. Patients should also be advised to stop using the product if symptoms clear up and then recur within a few days, and to refrain from using this or any other hydrocortisone product without prior consultation with a healthcare professional.

Additionally, patients should be instructed to avoid contact with the eyes while using this product. It is crucial to remind them not to exceed the recommended dosage unless directed by a doctor.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No further 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 Itch Relief Massaging Rollerball, 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 Itch Relief Massaging Rollerball, 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.