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Hydrocortisone 1%

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
March 2, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
March 2, 2023
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
part348
NDC root
63868-689
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Hydrocortisone cream is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to plants like poison ivy, oak, and sumac, as well as irritations from soaps, detergents, cosmetics, jewelry, and external feminine genital and anal itching.

This cream works by reducing inflammation and suppressing the immune response in the affected area, helping to alleviate discomfort and promote healing. While hydrocortisone cream can be effective for these uses, it's important to consult with a doctor for any other applications.

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, seborrheic dermatitis, and psoriasis. It can also help soothe itching from insect bites and reactions to plants like poison ivy, oak, and sumac. Additionally, it may relieve discomfort caused by soaps, detergents, cosmetics, jewelry, and external feminine genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. For best results, especially for external and anal itching, it’s a good idea to first clean the area with mild soap and warm water, rinsing thoroughly. Alternatively, you can gently pat or blot the area with toilet tissue or a soft cloth before applying the product.

If your child is under 2 years old, do not use this medication without consulting a doctor. Additionally, if a child under 12 years is experiencing external anal itching, it’s important to speak with a doctor before using this product. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely and effectively. You should not start using any other hydrocortisone product without first consulting your doctor. Additionally, make sure not to exceed the recommended daily dosage for treating external genital, feminine, and anal itching unless your doctor has specifically directed you to do so.

For your safety, avoid inserting this product into the rectum using your fingers or any medicated device or applicator. Following these guidelines will help ensure that you use the product correctly and minimize any potential risks.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens or if your symptoms last longer than 7 days. If your symptoms improve and then return within a few days, discontinue use and do not start any other hydrocortisone product unless your doctor advises you to do so.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes or for external genital itching if you have a vaginal discharge; in these cases, consult your doctor. Always keep this product out of the reach of children. If it is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last more than 7 days, or if symptoms clear up and then return within a few days. Do not start using any other hydrocortisone product without your doctor's guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that the cream is contraindicated (not recommended) for pregnant individuals, nor are there any stated risks to the fetus. Additionally, you do not need to make any dosage adjustments or take special precautions while using this cream during your pregnancy. However, it's always a good idea to consult with your healthcare provider before starting any new medication.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which could affect your nursing infant. Therefore, exercising caution is advised when considering this product while breastfeeding. Always prioritize your health and your baby's well-being by seeking professional guidance.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Additionally, if your child is under 12 years old and is experiencing external anal itching, you should also consult a doctor before using this treatment. Always prioritize your child's safety and seek professional advice when needed.

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, it’s important to consult with a healthcare provider for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. This ensures that you avoid any potential complications or interactions with your current medications. Your doctor can help you understand the best options for your health needs.

While there are no specific interactions with laboratory tests mentioned, maintaining open communication with your healthcare team about all medications and tests is crucial for your safety and well-being. Always feel free to ask questions and share your concerns.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 2 years and older. Make sure to apply it no more than 3 to 4 times a day for best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is hydrocortisone cream used for?

Hydrocortisone cream is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can hydrocortisone cream treat?

It is indicated for conditions such as eczema, seborrheic dermatitis, psoriasis, insect bites, poison ivy, soaps, detergents, cosmetics, jewelry, and external feminine genital and anal itching.

How should I apply hydrocortisone cream?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily.

Can children under 2 years use hydrocortisone cream?

No, children under 2 years of age should not use this product and should consult a doctor.

What should I do if my symptoms persist?

Stop using the product and ask a doctor if conditions worsen or if symptoms persist for more than 7 days.

Is hydrocortisone cream safe to use during pregnancy?

The insert does not provide specific warnings or precautions regarding the use of hydrocortisone cream during pregnancy.

What precautions should nursing mothers take?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow hydrocortisone cream?

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

Are there any contraindications for using hydrocortisone cream?

No specific contraindications are mentioned, but do not use for diaper rash or if you have a vaginal discharge without consulting a doctor.

How should I store hydrocortisone cream?

Store at controlled room temperature between 20°-25°C (68°-77°F).

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1%.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

qc hydrocortisone cream is a topical formulation containing hydrocortisone as the active ingredient. The product is presented in a 1-ounce (28.35 g) tube. The SPL Code for this formulation is 34089-3. The cream is designed for dermatological use, providing anti-inflammatory effects for the management of various skin conditions.

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, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching resulting from exposure to soaps, detergents, cosmetics, jewelry, and external feminine genital and anal areas.

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 adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Prior to application for external and anal itching, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing or gentle patting with toilet tissue or a soft cloth.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

Contraindications

The use of this product is contraindicated in the following situations:

Patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless directed by a physician. The product should not be administered rectally using fingers or any medicated device or applicator.

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 management. Additionally, it is contraindicated for use in cases of external genital itching accompanied by vaginal discharge; a consultation with a healthcare provider is recommended in such instances.

General precautions must be observed to ensure safe use. The product should be kept out of the reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Under no circumstances should patients resume use of this product or initiate any other hydrocortisone product without prior medical advice.

In cases of accidental ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should stop using this product and refrain from starting any other hydrocortisone product unless directed by a doctor.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone 1% (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone 1%.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and a consultation with a healthcare professional is advised. Additionally, pediatric patients under 12 years of age experiencing external anal itching should also consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The use of hydrocortisone cream during pregnancy does not have specific warnings or precautions outlined in the prescribing information. There is no indication that the product is contraindicated in pregnant patients, nor are there any documented risks to the fetus associated with its use. Additionally, the prescribing information does not recommend any dosage modifications or special precautions for women of childbearing potential. As with any medication, healthcare professionals should weigh the benefits against potential risks when considering treatment options for pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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 compound in these areas.

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 the reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens. Additionally, they should discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. It is important to emphasize that patients should not begin using any other hydrocortisone product unless directed by a healthcare professional.

When using this product, patients must be cautioned to avoid contact with the eyes. For those using the product for external genital, feminine, and anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a doctor. In the event of bleeding, patients should stop use and consult a doctor.

Finally, healthcare providers should instruct patients not to insert this product into the rectum using fingers or any medicated 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 room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone 1%, 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 1%, 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.