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Hydrocortisone

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Active ingredient
Hydrocortisone 10 mg/1 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 2013
Label revision date
September 8, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2013
Label revision date
September 8, 2025
Manufacturer
Unifirst First Aid Corporation
Registration number
M017
NDC root
47682-397
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

Hydrocortisone is a topical cream that contains 1% hydrocortisone, which is a type of medication used to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is particularly effective for external genital, feminine, and anal itching, helping to soothe discomfort and promote healing.

This cream is available under the brand name Green Guard and is designed for external use. While it can be beneficial for various skin issues, it's important to use it under the advice and supervision of a doctor for any other uses beyond the typical applications.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is also effective for alleviating itching in external genital areas, as well as feminine and anal itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision. This ensures that you use the product safely and effectively.

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 3 to 4 times a day. For children under 12 years old experiencing external anal itching, it’s important to consult a doctor before use. If your child is under 2 years old, do not use this product and seek advice from a healthcare professional.

For adults dealing with external anal itching, it’s best to start by gently cleansing the affected area with mild soap and warm water. Make sure to rinse thoroughly, or you can use a suitable cleansing pad to clean the area. After cleansing, gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying the medication. This preparation helps ensure the product works effectively.

What to Avoid

It's important to use this product safely. You should not use it for treating diaper rash, applying it in or around your eyes, or for feminine itching. Following these guidelines will help ensure your safety and the effectiveness of the product. If you have any questions or concerns about its use, please consult a healthcare professional.

Side Effects

This product is intended for external use only and should not be used for treating diaper rash, in the eyes, or for feminine itching. If your condition worsens, lasts more than 7 days, or clears and then comes back within a few days, you should stop using the product and consult a doctor. Additionally, if you experience any bleeding or plan to use another Hydrocortisone product, it's important to speak with a healthcare professional first.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes, for feminine itching, or to treat diaper rash. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, if you start using any other Hydrocortisone product, make sure to talk to your doctor first. If you notice any bleeding, stop using the product and seek medical advice.

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center immediately. Always prioritize your health and safety by following these guidelines.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It's always better to err on the side of caution when it comes to your health. If you are ever in doubt, contacting a healthcare professional or poison control center can provide you with the guidance you need.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's reassuring to know that there are no specific warnings, precautions, or dosage changes related to the use of Hydrocortisone cream mentioned in the drug insert. This means that, based on the available information, it is generally considered safe to use this cream during pregnancy.

However, it's always a good idea to consult with your healthcare provider before using any medication, including over-the-counter products, to ensure it is appropriate for your individual situation. Your doctor can provide personalized advice and address any concerns you may have.

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 it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When using this medication for children aged 2 years and older, you should apply it to the affected area 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, it's important to consult a doctor before use. For children under 2 years of age, you should not use this medication without first speaking to a doctor. Always prioritize your child's safety and seek 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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney health.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and avoid freezing it. It's important to keep the product in its original packaging, as it is tamper evident. This means that if you notice any opened or torn packets, you should not use them. Following these guidelines will help maintain the integrity of the product and ensure your safety.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone cream used for?

Hydrocortisone cream is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes, including external genital, feminine, and anal itching.

How should I apply Hydrocortisone cream?

For adults and children aged 2 years and older, apply to the affected area 3 to 4 times daily. For children under 12 years, consult a doctor for external anal itching.

Are there any contraindications for using Hydrocortisone cream?

The provided information does not specify any contraindications, but do not use it for diaper rash, in the eyes, or for feminine itching.

What should I do if my condition worsens?

Stop using Hydrocortisone cream and consult a doctor if your condition worsens, lasts more than 7 days, or if bleeding occurs.

Can I use Hydrocortisone cream while pregnant or nursing?

There are no specific pregnancy-related warnings, but nursing mothers should consult a doctor before use due to potential excretion in breast milk.

What are the storage instructions for Hydrocortisone cream?

Store Hydrocortisone cream at room temperature and do not freeze. Ensure packets are tamper evident and do not use any that are opened or torn.

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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes. It is also indicated for external genital, feminine, and anal itching.

Other uses of this product should be undertaken only 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 3 to 4 times daily. Prior to application, adults experiencing external anal itching are advised to cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 12 years of age, particularly for external anal itching, it is recommended to consult a doctor prior to use. The product is not indicated for use in children under 2 years of age; consultation with a healthcare professional is advised in such cases.

Contraindications

The product is contraindicated for the treatment of diaper rash. It should not be applied to the eyes, as this may lead to irritation or other adverse effects. Additionally, the product is not intended for use in alleviating feminine itching.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash, and it should not be applied to the eyes or used for feminine itching.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or persists for more than 7 days; the condition appears to improve and then recurs within a few days; or if the patient begins using any other Hydrocortisone product without prior consultation with a healthcare provider. Additionally, patients should seek immediate medical attention if bleeding occurs.

In the event of accidental ingestion, it is imperative to obtain medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for the treatment of diaper rash, application in the eyes, and for feminine itching.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if the condition worsens or persists for more than 7 days, or if symptoms clear and then recur within a few days. Additionally, patients should seek medical advice before using any other hydrocortisone product concurrently, unless they have consulted a doctor. The presence of bleeding during use also necessitates immediate cessation and consultation with a healthcare provider.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 the affected area 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use. The medication is contraindicated in children under 2 years of age; consultation with a doctor is necessary for this age group.

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

Hydrocortisone cream has not been associated with specific pregnancy-related warnings, precautions, or dosage modifications in the available prescribing information. While there is limited data on the use of hydrocortisone during pregnancy, healthcare professionals should consider the potential benefits and risks when prescribing this medication to pregnant patients.

As with any medication, it is advisable to use hydrocortisone cream only if clearly needed and to discuss the treatment options with women of childbearing potential. Further studies may be warranted to fully understand the implications of hydrocortisone use during pregnancy, particularly regarding fetal outcomes.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to obtain a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management of overdose may involve the use of specific antidotes, if available, and symptomatic treatment to address the manifestations of toxicity. Continuous monitoring of the patient is advised to detect any deterioration in their condition.

In all cases of suspected overdose, consultation with a poison control center or toxicology expert is recommended to ensure appropriate management and intervention strategies are employed.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep the 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 patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be kept at room temperature. It is important to note that freezing the product is not permitted, as it may compromise its integrity and effectiveness.

Additional Clinical Information

No further data are available.

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.