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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 2015
Label revision date
May 4, 2016
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 2015
Label revision date
May 4, 2016
Manufacturer
Dynarex Corporation
Registration number
part348
NDC root
67777-415
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 and provide a sense of relief when you experience these common skin issues.

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 adults, it's best to start by cleaning the affected area with mild soap and warm water, then rinse it thoroughly. After that, gently dry the area by patting it with bathroom tissue or a soft cloth before applying the medication. You can apply it externally up to 6 times a day or after each bowel movement.

If your child is under 2 years old, do not use this medication without first consulting a physician. It's important to follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this medication in your eyes or for diaper rash. It’s important not to use it for longer than one week unless your doctor specifically tells you to do so. If you have vaginal discharge, do not use this product. Always stick to the recommended daily dosage and never exceed it unless directed by a healthcare professional. Additionally, do not apply it in the rectum using your fingers or any mechanical device or applicator. Following these guidelines 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 persists or worsens, or if symptoms improve and then return within a few days, it's important to stop using the product and consult your physician. Additionally, if you are pregnant or breastfeeding, please seek medical advice before using this product.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas of your body. It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition does not improve or worsens, if your symptoms go away and then come back within a few days, or if you are pregnant or breastfeeding. Your health and safety are important, so don’t hesitate to reach out to a healthcare professional if you have any concerns.

Overdose

If you suspect an overdose, it's important to be aware that there is no specific information available about the effects of taking too much of this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical help immediately.

Signs of an overdose can vary, but they may include severe drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, or if you are unsure about your situation, do not hesitate to contact a healthcare professional or call emergency services for assistance. Your safety is the top priority, so it's always better to err on the side of caution.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to stop using this medication and consult your physician. Your healthcare provider can help you understand any potential risks and guide you on the best course of action for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you are taking during this time.

Lactation Use

If you are pregnant or breastfeeding, it's important to be aware of how certain medications can affect you and your baby. Some medications may be excreted in breast milk, which means they can pass to your nursing infant. This could potentially impact your baby's health, so it's crucial to consult with your healthcare provider about any medications you are considering or currently taking.

Always prioritize your baby's safety by discussing any concerns regarding breastfeeding and medication use. Your healthcare provider can help you weigh the benefits and risks, ensuring that both you and your baby remain healthy during this important time.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a physician (a medical doctor). For children aged 2 years and older, you can apply the medication evenly to the affected area, but be sure to do this no more than 3 or 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F - 77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. Adults can apply it up to 6 times daily or after each bowel movement, depending on your needs. Always follow your healthcare provider's instructions for the best results.

FAQ

What is Dynarex Hydrocortisone used for?

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

How should I apply Dynarex Hydrocortisone?

For adults and children 2 years of age, apply evenly to the affected area no more than 3 or 4 times daily. Adults may apply externally up to 6 times daily or after each bowel movement.

Can I use Dynarex Hydrocortisone on children under 2 years of age?

No, do not use Dynarex Hydrocortisone on children under 2 years of age without consulting a physician.

Are there any contraindications for using Dynarex Hydrocortisone?

Do not use Dynarex Hydrocortisone in the eyes, for diaper rash, if you have vaginal discharge, or in the rectum using fingers or any other device. Do not use longer than 1 week unless directed by a physician.

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

Stop use and ask a physician if the condition persists or gets worse, or if symptoms clear up and then appear again within a few days.

Is Dynarex Hydrocortisone safe to use during pregnancy or breastfeeding?

You should stop using Dynarex Hydrocortisone and consult a physician if you are pregnant or breastfeeding.

What precautions should I take when using Dynarex Hydrocortisone?

Keep Dynarex Hydrocortisone out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

What are the storage conditions for Dynarex Hydrocortisone?

Store Dynarex Hydrocortisone at 20°C to 25°C (68°F - 77°F) and avoid excessive heat and humidity.

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 inflammatory skin conditions. The formulations are designed to ensure stability and efficacy in delivering the therapeutic benefits of hydrocortisone.

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

For adults and children aged 2 years and older, the medication should be applied evenly to the affected area no more than 3 to 4 times daily. In adults, it is recommended that, when practical, the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting and blotting with bathroom tissue or a soft cloth prior to application.

Adults may apply the medication externally to the affected area up to 6 times daily or after each bowel movement, depending on the severity of the condition.

For children under 2 years of age, the use of this medication is not recommended, and consultation with a physician is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the eyes.

  • Use for a duration exceeding 1 week unless specifically directed by a physician.

  • Treatment of diaper rash.

  • Presence of vaginal discharge.

  • Administration of more than the recommended daily dosage unless directed by a doctor.

  • Insertion into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is not intended for internal use, and care should be taken to avoid ingestion.

General precautions must be observed to ensure safety. It is imperative to keep this product 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.

Patients should be advised to discontinue use and consult a physician under the following circumstances: if the condition persists or worsens, if symptoms resolve and then reappear within a few days, or if the patient is pregnant or breastfeeding. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

For external use only. Patients should discontinue use and consult a physician if the condition persists or worsens, if symptoms resolve and then reappear within a few days, or if they are pregnant or breastfeeding.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 not use this medication; consultation with a physician is advised. For children aged 2 years and older, the recommended application is to apply evenly to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients should discontinue use and consult a physician if they become pregnant or are breastfeeding. The potential risks associated with the use of this medication during pregnancy have not been fully established. Therefore, healthcare professionals are advised to carefully consider the benefits and risks before prescribing this medication to women of childbearing potential. It is essential to monitor fetal outcomes and provide appropriate counseling regarding the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers should be aware that the use of this medication is not recommended during breastfeeding. There is insufficient data regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, healthcare professionals should carefully consider the potential risks and benefits before prescribing this medication to lactating mothers.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive administration of the product.

Management Procedures In the absence of detailed guidance, standard protocols for managing drug overdosage should be followed. This may include gastric decontamination, administration of activated charcoal if appropriate, and supportive care tailored to the patient's needs. Consultation with a poison control center or toxicology expert is recommended for further guidance on management strategies.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to the ongoing assessment of the product's safety profile.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the 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 upon request. It should be stored at a controlled room temperature of 20°C to 25°C (68°F - 77°F). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety of the product.

Additional Clinical Information

The medication is administered topically, with specific guidelines for application. Adults and children aged 2 years and older should apply the product evenly to the affected area no more than 3 to 4 times daily. For adults, the application may be increased to up to 6 times daily or after each bowel movement, depending on the severity of the condition.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.