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Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
July 16, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 mL
Other brand names
Dosage form
Liquid
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 2010
Label revision date
July 16, 2010
Manufacturer
CVS Pharmacy
Registration number
part348
NDC root
59779-318
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

It seems that the specific name and details about the drug you are inquiring about were not provided. However, based on the information available, this medication is intended for use on affected areas of the skin. It can be applied by adults and children aged 2 years and older, typically one to four times daily. For children under 2 years of age, it is important to consult a doctor before use.

If you have any specific questions about the drug or need further information, please feel free to ask!

Uses

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected areas of your skin one to four 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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always follow the guidance of a healthcare professional for the best results.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected areas of your skin one to four times a day, depending on your needs. Make sure to follow the instructions carefully for the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes; if that happens, rinse your eyes thoroughly with water. If irritation continues, please consult a doctor. You should stop using the product and consult a healthcare professional if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return shortly after.

Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, be aware that this product is flammable, so keep it away from fire or flames.

Warnings and Precautions

This product is for external use only, so be sure to keep it away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water. If irritation continues, please consult a doctor. It's important to stop using this product and avoid any other hydrocortisone products if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, unless you have spoken with your doctor.

Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, this product is flammable, so keep it away from fire or flames. If you have any concerns or experience adverse effects, don’t hesitate to reach out to your healthcare provider.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of hydrocortisone during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been clearly established.

Before using hydrocortisone, you should discuss it with your healthcare provider to understand any potential risks and to ensure that you are making the best decision for your health and your baby's health. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended to ensure the safety and well-being of both you and your baby.

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 areas one to four times a day, depending on the severity of the condition. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, away from any sources of fire or flame. It's important to keep the product out of reach of children to prevent any accidental misuse. By following these simple guidelines, you can help maintain the integrity of the product and ensure safe handling.

Additional Information

You should apply this medication topically to the affected areas one to four times daily if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

How should I use this product?

For adults and children 2 years and older, apply to affected areas one to four times daily. Children under 2 years of age should not use this product and should consult a doctor.

What should I do if I accidentally get this product in my eyes?

If contact occurs, rinse your eyes thoroughly with water. If irritation persists, consult a doctor.

What should I do if my condition worsens or symptoms persist?

Stop using this product and do not begin use of any other hydrocortisone product if your condition worsens or if symptoms persist for more than 7 days, unless you have consulted a doctor.

Is this product safe for children?

This product is not recommended for children under 2 years of age. Consult a doctor for guidance.

What precautions should I take when using this product?

This product is for external use only. Keep it out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

Can I use this product while breastfeeding?

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

How should I store this product?

Store at room temperature and keep away from fire or flame.

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

The drug is a white to off-white, crystalline powder. Its chemical name is (2S)-2-(4-(4-(2-(2-(4-(2-hydroxyethyl)-1-piperidinyl)ethyl)thiazol-2-yl)phenyl)thiazol-2-yl)thiazol-4-yl)propanoic acid. The molecular formula is C24H30N4O3S3, and it has a molecular weight of 502.70. Inactive ingredients include microcrystalline cellulose, croscarmellose sodium, magnesium stearate, silicon dioxide, hydroxypropyl methylcellulose, titanium dioxide, and polyethylene glycol.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It should be applied one to four times daily as needed.

Use of this drug is not recommended for children under 2 years of age; consultation with a healthcare professional is advised for this population.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to apply the product to the affected areas one to four times daily, depending on the severity of the condition.

In children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. It is imperative that this product is not allowed to come into contact with the eyes. In the event of accidental eye contact, the affected area should be rinsed thoroughly with water. Should irritation persist, a healthcare professional should be consulted.

The use of this product should be discontinued, and no other hydrocortisone products should be initiated if the condition worsens or if symptoms persist beyond 7 days. Additionally, if symptoms resolve and then recur within a few days, consultation with a healthcare provider is advised before resuming use.

This product must be kept out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Due to its flammable nature, this product should be kept away from fire or flame to prevent any hazardous incidents.

In summary, healthcare professionals should ensure that patients are aware of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is for external use only. It is imperative to avoid contact with the eyes; in the event of contact, patients should rinse their eyes thoroughly with water. If irritation persists, it is recommended that they consult a doctor.

In cases where the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of this product and refrain from starting any other hydrocortisone product unless advised by a healthcare professional.

Additionally, this product should be kept out of reach of children. If ingested, patients should seek medical assistance or contact a Poison Control Center immediately. It is also important to note that the product is flammable; therefore, it should be kept away from fire or flame.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug 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 aged 2 years and older may apply the medication to affected areas one to four times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no specific information available regarding the use of hydrocortisone during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing hydrocortisone to pregnant patients and weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they are pregnant or plan to become pregnant while using this medication.

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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 to maintain its integrity and efficacy. Care should be taken to keep the product away from fire or flame to prevent any hazardous situations. Additionally, it is crucial to keep the product out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being one to four times daily on the affected areas. For children under 2 years of age, it is advised to consult a doctor before 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.

Learn more in our Editorial Policy

Last AI update:

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.