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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 2020
Label revision date
November 17, 2023
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 2020
Label revision date
November 17, 2023
Manufacturer
BluePoint Laboratories
Registration number
M017
NDC root
68001-476
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

Hydrocortisone Cream, USP 1% is a topical medication designed to provide temporary relief from itching and discomfort associated with various minor skin irritations. This includes conditions such as eczema, insect bites, and rashes caused by poison ivy, poison oak, or poison sumac. It can also help alleviate itching related to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching.

By applying this cream to the affected area, you can soothe your skin and reduce inflammation, making it a helpful option for managing these common skin issues.

Uses

You can use this medication for temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, detergents, cosmetics, and jewelry, as well as conditions like seborrheic dermatitis and psoriasis. Additionally, it may provide relief for external genital, feminine, and anal itching.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication.

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. For children under 2 years old, it’s important to consult a doctor before use.

If you are using this medication for anal itching, start by cleaning the affected area with mild soap and warm water, then rinse it thoroughly. After that, gently dry the area by patting or blotting it with bathroom tissue or a soft cloth before applying the medication. If the user is a child under 12, make sure to consult a doctor before using it for anal itching as well.

What to Avoid

You should avoid using this product in your eyes or for treating diaper rash. If you have a vaginal discharge, do not use it for external genital or feminine itching. It's important to stick to the recommended daily dosage and not exceed it unless your doctor advises otherwise. Additionally, do not use this product in the rectum with your fingers or any mechanical device or applicator. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

You should only use this product on the skin and avoid contact with your eyes. It is not suitable for treating diaper rash or external genital itching if you have a vaginal discharge. Be sure to follow the recommended dosage and do not use it in the rectum with fingers or any devices.

If your condition worsens, symptoms last more than 7 days, or if they improve and then return shortly after, stop using the product and consult a doctor. Additionally, if you experience any bleeding while using it for anal itching, seek medical advice. If the product is swallowed, get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Avoid applying it in your eyes, on diaper rashes, or for external genital itching if you have a vaginal discharge. Do not exceed the recommended daily dosage unless directed by your doctor, and do not use it in the rectum with fingers or any device.

Before using this product, check with your doctor if you are already using any other hydrocortisone (a type of steroid used to reduce inflammation) products. You should stop using it and contact your doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you experience any bleeding while using it for anal itching, seek medical advice. Always keep this product out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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 up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before use. Additionally, if your child is under 12 and you are considering it for anal itching, it's best to check with a doctor first to ensure it's safe for them. 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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 determine the best course of action based on your kidney function and overall 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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are already using any other hydrocortisone products. Combining different hydrocortisone treatments can lead to unexpected effects, so your doctor can help ensure that you use them safely and effectively. Always keep your healthcare team informed about all the medications and treatments you are using to avoid potential interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the seal on the tube is intact and visible before use. To open the tube, simply unscrew the cap and pull the tab to remove the foil seal. It's important to store the product at room temperature and to keep it away from excessive heat. Make sure to preserve it in a well-closed container to maintain its quality.

Additionally, be sure to check the crimp of the tube or carton for the Lot Number and Expiry Date, as this information is crucial for tracking and safety. Following these guidelines will help you handle and store the product properly.

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 postmarketing experiences related to this medication.

FAQ

What is Hydrocortisone Cream used for?

Hydrocortisone Cream is used for temporary relief of 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. Consult a doctor for children under 2 years.

Are there any contraindications for using Hydrocortisone Cream?

Yes, do not use it in the eyes, for diaper rash, or for external genital itching if you have a vaginal discharge. Also, do not exceed the recommended dosage.

What should I do if my condition worsens?

Stop using Hydrocortisone Cream and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if bleeding occurs when used for anal itching.

Can I use Hydrocortisone Cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Hydrocortisone Cream.

What should I do if I accidentally swallow Hydrocortisone Cream?

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

How should I store Hydrocortisone Cream?

Store Hydrocortisone Cream at room temperature, avoid excessive heat, and keep it in a well-closed container.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone (antipruritic (anti-itch)). 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, USP 1%, is presented in a 30g (1.05 oz) tube. This formulation contains hydrocortisone as the active ingredient, providing a topical corticosteroid for the management of inflammatory skin conditions. The cream is designed for external use and is characterized by its specific concentration and dosage form, ensuring effective delivery of the active compound.

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. These conditions include eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it is indicated for seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed 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 essential to consult a doctor prior to use.

In cases of anal itching, it is recommended to first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, gently dry the area by patting or blotting with bathroom tissue or a soft cloth before applying the medication. For children under 12 years of age, consultation with a doctor is advised before using the medication for anal itching.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential harm.

  • The product should not be used for diaper rash, as it is not indicated for this condition.

  • It is contraindicated for external genital or feminine itching in patients with vaginal discharge, due to the risk of exacerbating underlying conditions.

  • Exceeding the recommended daily dosage is not advised unless specifically directed by a healthcare professional.

  • The product must not be administered rectally using fingers or any mechanical device or applicator, as this may lead to complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional prior to use.

The product should not be applied in the eyes, used for diaper rash, or for external genital or feminine itching in the presence of vaginal discharge. Additionally, it is imperative that patients do not exceed the recommended daily dosage unless directed by a physician. The use of this product in the rectum, whether by fingers or any mechanical device or applicator, is contraindicated.

Patients should be instructed to consult a doctor before using this product if they are concurrently using any other hydrocortisone product.

If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients must discontinue use and seek medical advice. Furthermore, if bleeding occurs while using the product for anal itching, medical consultation is necessary.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use in the eyes, for diaper rash, and for external genital or feminine itching in the presence of vaginal discharge. Additionally, patients should not exceed the recommended daily dosage unless directed by a healthcare professional, nor should the product be used in the rectum with fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The use of this product should also be stopped in the event of bleeding when applied for anal itching.

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

Drug Interactions

The concurrent use of hydrocortisone with other hydrocortisone-containing products should be approached with caution. It is advisable for patients to consult a healthcare professional prior to initiating treatment with hydrocortisone if they are currently using any other hydrocortisone formulations. This is to prevent potential additive effects and to ensure appropriate management of dosage and therapeutic outcomes. Monitoring for signs of excessive corticosteroid exposure may be warranted in such cases.

Packaging & NDC

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

Packaging configurations for Hydrocortisone.
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 prior to use. Additionally, for children under 12 years, consultation with a doctor is recommended before using the medication for anal itching.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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 and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a tube format, and it is essential to ensure that the seal on the tube is intact and visible before use. To open the tube, the user should unscrew the cap and pull the tab to remove the foil seal.

Storage conditions require the product to be kept at room temperature, away from excessive heat. It is important to preserve the product in a well-closed container to maintain its integrity. For reference, the Lot Number and Expiry Date can be found on the crimp of the tube or on the carton.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.