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Cortisone

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Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
October 31, 2024
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2012
Label revision date
October 31, 2024
Manufacturer
CVS Pharmacy
Registration number
M017
NDC root
59779-878

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Drug Overview

Hydrocortisone 1% is an anti-itch lotion designed to provide fast relief for eczema and dry, itchy skin. It works by temporarily relieving itching associated with minor skin irritations, rashes, and inflammation due to eczema. This lotion is clinically proven to moisturize for 24 hours and contains botanicals along with antioxidant vitamins A, C, and E, making it a soothing option for your skin.

In addition to its primary use for itching and irritation, Hydrocortisone 1% is formulated with seven intensive moisturizers and is hypoallergenic, ensuring it is gentle on the skin. It is available over-the-counter and is comparable to the active ingredient found in Cortizone•10 Intensive Healing Lotion.

Uses

You can use this product to temporarily relieve itching caused by minor skin irritations, rashes, and inflammation related to eczema. It's important to note that for any other uses, you should consult with your doctor for advice and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. Always prioritize your health and seek professional guidance when needed.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult with a doctor before using this medication. They can provide the necessary guidance to ensure safety and effectiveness. Always follow your healthcare provider's instructions for the best care.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; if you have concerns about this condition, please consult your doctor. Additionally, avoid getting the medication in your eyes, as this can cause irritation. Always follow the dosage instructions carefully and do not exceed the recommended amount unless your doctor advises you to do so. Your safety is a priority, so if you have any questions or uncertainties, reach out to your healthcare provider.

Side Effects

This medication is intended for external use only. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, you should stop using it and consult a doctor. It's important not to start any other hydrocortisone product without medical advice.

In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rash. If you have any concerns, it's best to consult your doctor.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, stop using the product and reach out to your doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days. Do not start using any other hydrocortisone product without consulting your doctor first.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned about using hydrocortisone lotion during pregnancy. This means that the information available does not indicate any necessary dosage changes or special precautions for its use while you are expecting.

As always, it's best to consult with your healthcare provider before using any medication, including over-the-counter products like hydrocortisone lotion, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use hydrocortisone lotion without specific warnings or recommendations against it. The information available does not indicate any concerns about the lotion being passed into breast milk or posing any risk to your infant.

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

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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. If you or a loved one is an older adult, it’s wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Always ensure that your doctor is aware of any other medications you are taking, as well as any existing health conditions. This will help them determine the safest and most effective dosage for you. Remember, your health and safety are the top priorities when considering new medications.

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 is safe and effective, especially if you have any concerns about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to ensure the best outcomes for your health.

Storage and Handling

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

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and optimal results. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You can apply this medication to the affected area of your skin up to 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 of age, it's important to consult a doctor before use.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch lotion that temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema.

How should I use Hydrocortisone 1%?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using Hydrocortisone 1%?

Do not use Hydrocortisone 1% for the treatment of diaper rash and avoid contact with eyes.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is Hydrocortisone 1% safe to use during pregnancy?

There is no specific information regarding the use of Hydrocortisone 1% during pregnancy in the provided text.

What should I do if I accidentally swallow Hydrocortisone 1%?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What are the storage conditions for Hydrocortisone 1%?

Store Hydrocortisone 1% at 20-25°C (68-77°F).

Can I use Hydrocortisone 1% for other skin conditions?

Other uses of this product should only be under the advice and supervision of a doctor.

Packaging Info

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

Packaging configurations for Cortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CVS Health® Maximum Strength Anti-Itch Lotion contains hydrocortisone 1% as its active ingredient, comparable to the active ingredient in Cortizone•10® Intensive Healing Lotion. This long-lasting healing lotion is designed to provide fast relief for eczema and dry, itchy skin. It is formulated with seven intensive moisturizers and includes botanicals along with antioxidant vitamins A, C, and E. The lotion is hypoallergenic and clinically proven to deliver 24-hour moisturization. Each container has a net weight of 3.5 oz (99 g) and is compliant with OTC Monograph standards.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, rashes, and inflammation due to eczema.

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

There are no teratogenic or nonteratogenic effects associated with this drug.

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, it is advised to consult a physician prior to use. This precaution ensures that appropriate guidance is provided based on the individual needs of the child.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

Additionally, contact with the eyes should be avoided to prevent irritation. The product should not be used in excess of the directed 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; healthcare professionals should advise patients to consult a doctor for appropriate alternatives.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

Side Effects

Patients using this product should be aware that it is for external use only. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. It is important not to begin the use of any other hydrocortisone product without prior consultation with a healthcare professional.

In cases where the product is swallowed, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Cortisone.
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, it is advised to consult a doctor before use.

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 are no specific statements regarding the use of hydrocortisone lotion during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone lotion in lactating mothers. Additionally, there is no information available about the potential for excretion of hydrocortisone 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate actions to take.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 important to instruct patients to avoid contact with the eyes while using this product.

Healthcare providers should emphasize that patients must not exceed the recommended dosage unless directed by a physician. Patients should also be counseled 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. Additionally, patients should be advised not to start using any other hydrocortisone product without first consulting a healthcare professional.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to ensure that the storage environment maintains this temperature range to preserve the integrity of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied 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 doctor before use. 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 Cortisone, 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 Cortisone, 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.