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Hydrocortisone

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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 2016
Label revision date
June 23, 2017
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 2016
Label revision date
June 23, 2017
Manufacturer
Dynarex Corporation
Registration number
part348
NDC root
67777-417
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

Dynarex Hydrocortisone is a medication designed to provide temporary relief from minor skin irritations and external itching. It is commonly used to soothe discomfort caused by various skin conditions, helping to alleviate symptoms and promote comfort. If you're experiencing minor skin issues, this product may be a helpful option for you.

Uses

You can use this medication for the temporary relief of minor skin irritations and external itching. It’s designed to help soothe discomfort caused by various skin issues, allowing you to feel more comfortable in your daily activities.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication evenly to the affected area up to 3 or 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 cleansing the affected area with mild soap and warm water, then rinse it thoroughly. After that, gently dry the area by patting and blotting with bathroom tissue or a soft cloth before applying the medication. If the user is a child under 12, it’s also advisable to consult a doctor before using it for anal itching.

What to Avoid

You should be aware of several important guidelines when using this medication. First, do not apply it to your eyes or use it for diaper rash. It's also crucial to avoid using it for longer than one week unless your doctor specifically instructs you to do so. If you have vaginal discharge, refrain from using this product. Always stick to the recommended daily dosage, and do not exceed it unless directed by a healthcare professional. Additionally, do not use this medication in the rectum with your fingers or any other device. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using it and consult a doctor. Additionally, if you experience any bleeding while using it for anal itching, seek medical advice immediately.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If it is accidentally ingested, seek medical help or contact a Poison Control Center immediately. Keep this product out of reach of children to prevent any accidental ingestion.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Additionally, if you experience any bleeding while using it for anal itching, stop use and contact your doctor right away.

Overdose

Taking more than the recommended daily dosage of a medication can lead to an overdose. This means you might be using more of the drug than is safe, unless your doctor has specifically instructed you to do so.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. It’s important to seek immediate medical help if you notice any of these symptoms or if you have taken more than the recommended amount. Always consult your healthcare provider if you have any concerns about your medication usage.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone cream during pregnancy has not been established. Therefore, it is generally not recommended to use this cream unless your doctor specifically advises you to do so. There may be potential risks to your developing baby, so it's crucial to consult your healthcare provider for personalized advice.

Additionally, if you do need to use hydrocortisone cream while pregnant, your doctor may suggest adjustments to the dosage. Always seek guidance from your healthcare provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that hydrocortisone cream is passed into breast milk or poses any risk to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication evenly to the affected area, but make sure to do this no more than 3 or 4 times a day. If your child is under 12 and experiencing anal itching, please consult a doctor before using the product to ensure it's safe and appropriate for their needs.

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 before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from excessive heat, as high temperatures can affect its effectiveness.

When handling the product, make sure to do so with clean hands or in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 or 4 times a day if you are an adult or a child aged 2 years and older. If the medication is being used for anal itching, make sure to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication. If you are a parent, consult a doctor before using this medication for children under 12 years old or for any child under 2 years of age.

FAQ

What is Dynarex Hydrocortisone used for?

Dynarex Hydrocortisone is used for temporary relief of minor skin irritations and external itching.

What is the recommended dosage for adults and children over 2 years?

Adults and children 2 years of age and older should apply it evenly to the affected area no more than 3 or 4 times daily.

What should I do if I am under 2 years old?

If you are under 2 years of age, you should consult a doctor before using this product.

Are there any contraindications for using Dynarex Hydrocortisone?

Yes, do not use it in the eyes, for diaper rash, or if you have vaginal discharge. Also, do not use it longer than 1 week unless directed by a physician.

What should I do if my condition worsens or does not improve?

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

Is it safe to use Dynarex Hydrocortisone during pregnancy?

The safety of hydrocortisone cream during pregnancy has not been established, and it is not recommended unless directed by a physician.

What precautions should I take when using this medication?

Keep Dynarex Hydrocortisone out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

How should I store Dynarex Hydrocortisone?

Store Dynarex Hydrocortisone at room temperature and avoid excessive heat.

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

Dynarex Hydrocortisone Items 1137 and 1139 are pharmaceutical preparations containing hydrocortisone as the active ingredient. These items are formulated for topical application and are designed to provide anti-inflammatory and antipruritic effects. The products are presented in a cream dosage form, characterized by a smooth, white appearance. Each item is specifically indicated for the relief of various dermatological conditions.

Uses and Indications

This drug is indicated for the temporary relief of minor skin irritations and external itching.

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication evenly 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 anal itching, it is essential to cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting and blotting with bathroom tissue or a soft cloth before application of the medication. For children under 12 years of age, consultation with a healthcare professional is recommended 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.

  • Prolonged use beyond one week is not recommended unless specifically directed by a physician, to avoid adverse effects.

  • The product should not be used for diaper rash, as it may not be appropriate for that condition.

  • Use is contraindicated in patients with vaginal discharge, as this may indicate an underlying condition that requires different management.

  • Exceeding the recommended daily dosage is not advised unless directed by a healthcare professional, to prevent toxicity or other complications.

  • The product should not be administered rectally using fingers or any mechanical device or applicator, as this may lead to injury or improper use.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician 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. Additionally, if there is any bleeding associated with the use of this product for anal itching, patients should stop use and seek medical advice promptly.

In cases of ingestion, emergency medical help must be obtained immediately, or a Poison Control Center should be contacted.

No specific laboratory tests are recommended for monitoring the use of this product.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if bleeding occurs when the product is used for anal itching, patients are advised to stop use and seek medical advice.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

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 under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the medication may be applied evenly to the affected area no more than 3 or 4 times daily. Additionally, for children under 12 years of age, it is advised to consult a doctor 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, given the lack of targeted data for this population.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Its use is not recommended during pregnancy unless directed by a physician. There may be potential risks to the fetus, and it is essential for pregnant patients to consult a healthcare provider for personalized advice. Additionally, dosage adjustments may be necessary for pregnant individuals; therefore, healthcare providers should be consulted for specific recommendations regarding the use of hydrocortisone cream in this population.

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. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the clinical situation and the absence of documented risks.

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

Overdosage may occur when a patient exceeds the recommended daily dosage of the medication, unless specifically directed by a healthcare professional.

In the event of suspected overdosage, it is crucial for healthcare providers to assess the patient's condition promptly. Symptoms of overdosage can vary depending on the specific medication involved and may include a range of adverse effects.

Management of overdosage should involve immediate medical intervention. Healthcare professionals are advised to contact a poison control center or seek emergency medical assistance to ensure appropriate treatment is administered. Monitoring of the patient’s vital signs and supportive care may be necessary, depending on the severity of the symptoms presented.

It is essential to educate patients on the importance of adhering to prescribed dosages and to encourage them to consult their healthcare provider if they have any questions or concerns regarding their medication regimen.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

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 room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent any potential degradation of the product.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. For adults and children aged 2 years and older, it should be applied evenly to the affected area no more than 3 or 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use. In cases of anal itching, it is recommended to cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting and blotting with bathroom tissue or a soft cloth before application. Additionally, for children under 12 years, a doctor's consultation is necessary before using the product for anal itching.

No further information is 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.

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.