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Hydrocortisone

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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 2011
Label revision date
September 25, 2024
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 2011
Label revision date
September 25, 2024
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Registration number
M017
NDC root
45802-438
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Hydrocortisone Cream 1% is a maximum strength anti-itch cream designed to provide fast relief from itching and redness. It works by helping to heal rashes, making your skin healthier. This cream is effective for temporarily relieving itching associated with minor skin irritations, inflammation, and rashes caused by conditions such as eczema, insect bites, poison ivy, soaps, detergents, cosmetics, and even psoriasis.

You can also use it to alleviate external anal and genital itching. However, for other uses, it's important to consult with a doctor for proper 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 such as eczema, insect bites, and reactions to poison ivy, oak, or sumac. It can also help with irritation from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. Additionally, it offers temporary relief for external anal and genital itching.

For any other uses, it's important to consult with your doctor for advice 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 gently drying the area by patting or blotting with toilet tissue or a soft cloth, you can apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid using more than the recommended amount unless directed by your doctor, and do not insert it directly into the rectum using fingers or any device.

If you experience rectal bleeding, notice that your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult your doctor. While using this product, be careful to avoid contact with your eyes.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you experience rectal bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

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. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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. It’s important not to insert the product directly into the rectum using fingers or any devices.

If you experience rectal bleeding, if your condition worsens, or if symptoms persist for more than 7 days (or improve and then return within a few days), stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 on 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

While there are no specific guidelines regarding the use of hydrocortisone cream during pregnancy, the information provided does not indicate any safety concerns, contraindications, or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

If you are considering using hydrocortisone cream while pregnant, it is always a good idea to consult with your healthcare provider to ensure it is appropriate for your situation.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. Currently, there is no information indicating that this cream is passed into breast milk or that it poses any risk to your nursing infant. Always feel free to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

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, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please consult a doctor for guidance on how to proceed. Always prioritize your child's safety and well-being 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 always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 should be used if you have hepatic impairment (liver issues).

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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 the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

Additional Information

For treating itching caused by 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. If you are dealing with external anal or genital itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting with toilet tissue or a soft cloth before applying the medication. Again, you should apply it no more than 3 to 4 times daily.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

How should I apply Hydrocortisone Cream?

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 precautions I should take when using this cream?

Avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use this cream for diaper rash?

No, do not use Hydrocortisone Cream for the treatment of diaper rash; consult a doctor instead.

What should I do if my condition worsens?

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

Is it safe to use Hydrocortisone Cream during pregnancy?

The insert does not provide specific information regarding the use of hydrocortisone cream during pregnancy.

What should I do if I accidentally swallow the cream?

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

What are the side effects of Hydrocortisone Cream?

The insert does not list specific side effects, but you should stop use and consult a doctor if you experience rectal bleeding or worsening symptoms.

Packaging Info

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

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Cream 1% is a topical formulation designed for the relief of itching and inflammation. This cream is presented in a net weight of 1 ounce (28 grams) and is manufactured by Padagis®. The product contains hydrocortisone as the active ingredient at a concentration of 1%, providing maximum strength for effective anti-itch relief.

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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. 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 cleanse 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 no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before application.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is contraindicated in patients with vaginal discharge; medical consultation is advised.

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

  • The product should not be applied directly into the rectum using fingers or any mechanical device or applicator.

  • Use beyond the directed dosage is contraindicated unless specifically instructed by a healthcare provider.

Healthcare professionals should advise patients to discontinue use and seek medical advice if rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution. Additionally, contact with the eyes should be avoided during use.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; 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 should not exceed 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 rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, consultation with a healthcare professional is necessary before using this or any other hydrocortisone product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) 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 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. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. If symptoms clear up and then recur within a few days, patients should refrain from using this or any other hydrocortisone product without consulting a doctor.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with 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 Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication 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 cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years of age, it is recommended to seek medical advice before using the product.

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 cream during pregnancy in the available prescribing information. The insert does not mention any safety concerns, contraindications, or special precautions related to the use of hydrocortisone cream in pregnant patients. Additionally, there are no dosage modifications provided for individuals who are pregnant. As such, healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream 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 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 established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical 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. The national Poison Control Center can be reached at 1-800-222-1222.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience includes reports of various adverse reactions associated with the use of the product. These reactions encompass skin irritation, allergic reactions, contact dermatitis, hypopigmentation, and secondary infections. Additionally, systemic effects, such as adrenal suppression, have been noted with prolonged use or application over large areas.

Further safety updates may provide information regarding the potential for an increased risk of adverse reactions in specific populations or when used concurrently with certain medications.

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 at 1-800-222-1222.

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 emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients to stop using the product and consult a doctor if rectal bleeding occurs. Patients should also be advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is crucial to inform patients that they should not use this or any other hydrocortisone product without consulting a doctor.

While using this product, patients should be cautioned to avoid contact with their eyes. Providers should also remind patients not to exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. In cases of external anal and genital itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application. This should also be done no more than 3 to 4 times daily.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, 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 Hydrocortisone, 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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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.