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Cortizone 10 Water Resistant

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
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 2023
Label revision date
July 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
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 2023
Label revision date
July 1, 2025
Manufacturer
Chattem, Inc.
Registration number
M017
NDC root
41167-0344
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Cortizone 10 is a water-resistant ointment that contains 1% hydrocortisone, which is a type of medication used to relieve itching. You can use it for minor skin irritations, inflammation, and rashes caused by conditions such as eczema, psoriasis, poison ivy, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it can help alleviate external anal and genital itching.

This ointment works by temporarily reducing inflammation and itching, providing you with comfort when dealing with these skin issues. However, for any other uses, it's important to consult with a doctor for proper guidance.

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.

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 important to consult a doctor before using this treatment.

For external itching around 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 medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash without consulting a doctor. Additionally, avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

If you have any questions or concerns about using this medication, please reach out to your doctor for guidance. Your health and safety are the top priority.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless your doctor advises otherwise. If you experience worsening symptoms, if your condition doesn't improve after 7 days, or if you notice rectal bleeding, stop using the product and consult your doctor. Additionally, this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor.

If the product is swallowed, seek medical help or contact a Poison Control Center immediately. Always prioritize your health and safety by following these guidelines.

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 seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

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, acting quickly can make a significant difference in the outcome.

Pregnancy Use

When it comes to using Cortizone 10 Water Resistant hydrocortisone ointment 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 ointment on you or your developing baby are not well-studied or documented.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

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. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

When it comes to treating skin irritation, inflammation, and rashes in children, you can apply the medication to the affected area up to 3 to 4 times daily for kids aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use. For external anal and genital itching, adults should clean the area with mild soap and warm water, then apply the medication as needed. If your child is under 12 years old, please check with a doctor first.

Always keep this medication out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

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 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 (issues with liver function).

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 monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use the contents within a specified time frame, please discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For both adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're dealing with external anal and genital itching, adults should also apply it to the affected area up to 3 to 4 times daily. Always follow the recommended application frequency for the best results.

FAQ

What is Cortizone 10?

Cortizone 10 is a water-resistant ointment containing 1% hydrocortisone, used as an anti-itch treatment for minor skin irritations.

What conditions does Cortizone 10 relieve?

It temporarily relieves itching associated with eczema, psoriasis, poison ivy, insect bites, and other minor skin irritations.

How should I use Cortizone 10?

For adults and children 2 years and older, apply to the affected area 3 to 4 times daily. For children under 2, consult a doctor.

Are there any contraindications for using Cortizone 10?

Do not use it in the genital area if you have a vaginal discharge or for diaper rash without consulting a doctor.

What should I do if I experience side effects?

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

Can I use Cortizone 10 while pregnant or nursing?

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

What precautions should I take when using Cortizone 10?

Avoid contact with eyes, do not exceed the recommended dosage, and do not apply directly into the rectum.

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 at room temperature, protect from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Cortizone 10 Water Resistant.
Details

Drug Information (PDF)

This file contains official product information for Cortizone 10 Water Resistant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Cortizone 10 is a water-resistant ointment formulated with 1% hydrocortisone, designed for the relief of itching. This anti-itch ointment is presented in 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, the use of this medication is not recommended; consultation with a healthcare professional 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 medication 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 healthcare professional 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; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

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

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised. It is also not recommended for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed by a healthcare provider. Additionally, the product should not be administered directly into the rectum using fingers, mechanical devices, or applicators.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if rectal bleeding is observed. It is advised not to initiate the use of any other hydrocortisone product without consulting a healthcare professional.

In the event 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 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 consultation.

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, medical attention should be sought if rectal bleeding occurs.

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

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 Cortizone 10 Water Resistant (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cortizone 10 Water Resistant.
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, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before applying the product. For children under 12 years of age, it is recommended to seek medical advice before use.

It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no information available regarding the use of Cortizone 10 Water Resistant hydrocortisone ointment during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to 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 in nursing mothers. Additionally, there is no information available about 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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

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 that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients should be instructed 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. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a healthcare professional. Furthermore, patients should be made aware that they 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 their eyes. It is essential to emphasize that they should not exceed the recommended dosage unless directed by a doctor. Lastly, 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 a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within a specified time frame.

Additional Clinical Information

The product is administered topically for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It is recommended that the affected area be treated no more than 3 to 4 times daily. For external anal and genital itching in adults, the same frequency of application is advised.

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

Drug Information (PDF)

This file contains official product information for Cortizone 10 Water Resistant, 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 Water Resistant, 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.