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Hydrocortisone 1%

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Active ingredient
Hydrocortisone 1 g/100 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 2023
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2023
Label revision date
December 17, 2024
Manufacturer
Geri-Care Pharmaceuticals, Corp
Registration number
M017
NDC root
57896-146
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

Gericare Hydrocortisone 0.9g is a medication designed to provide temporary relief from itching caused by minor skin irritations and rashes. It is particularly effective for external feminine, genital, and anal itching, helping to soothe discomfort in these sensitive areas.

While it can be beneficial for these specific uses, it's important to consult with a doctor for any other applications to ensure safe and appropriate use.

Uses

You can use this product for temporary relief from itching caused by minor skin irritations and rashes. It is also effective for alleviating external itching in feminine, genital, and anal areas. However, for any other uses, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching, skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using this medication.

For external and anal itching in adults, start by gently cleaning the affected area with mild soap and warm water, then rinse thoroughly. After cleaning, pat or blot the area dry with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, be sure to ask a doctor for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not use it for treating diaper rash without first consulting a doctor. Additionally, avoid using it alongside any other hydrocortisone products unless directed by a healthcare professional. If you experience a vaginal discharge, please consult your doctor before using this product.

If your condition worsens, symptoms last longer than 7 days, or if symptoms improve and then return shortly after, stop using the product and seek medical advice. You should also discontinue use if you notice rectal bleeding. While using this medication, keep it away from your eyes, do not exceed the recommended dosage unless advised by a doctor, and avoid inserting it into the rectum with fingers or any devices.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then come back within a few days. Additionally, if you experience rectal bleeding, discontinue use immediately 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 any internal areas. Keep it out of reach of children, and 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 longer than 7 days, or if symptoms improve and then come back within a few days. Additionally, discontinue use if you experience rectal bleeding, and do not start any other hydrocortisone product unless your doctor advises you to do so.

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

When considering the use of Hydrocortisone 1% cream during pregnancy, it's important to note that the provided information does not include specific statements about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how this medication may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter creams like Hydrocortisone. They can help you weigh the potential benefits and risks based on your individual health needs.

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

If your child is experiencing itching, skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important not to use this medication without consulting a doctor first.

For children under 12 years of age, you should also check with 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 considering this medication, it’s important to consult with a healthcare provider. 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 apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need 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 be cautious when using hydrocortisone products. You should avoid using this product alongside any other hydrocortisone products unless you have consulted with your doctor. If you need to stop using this product, do not start any other hydrocortisone product without your doctor's guidance.

While there are no specific interactions with other medications or lab tests noted, discussing all your medications and any upcoming tests with your healthcare provider is essential. This ensures your safety and helps manage your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality. Always check the packaging before use; do not use the product if the packet is torn, cut, or opened, as this indicates it may have been tampered with.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its safe use.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. For adults specifically dealing with external and anal itching, the same application frequency applies. Always follow the recommended usage to ensure safety and effectiveness.

FAQ

What is Gericare Hydrocortisone used for?

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

How should I apply Gericare Hydrocortisone?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, do not use without consulting a doctor.

Are there any contraindications for using this product?

Yes, do not use for the treatment of diaper rash, with any other hydrocortisone product unless advised by a doctor, or if you have a vaginal discharge.

What should I do if my symptoms worsen?

Stop using the product and consult a doctor if conditions worsen, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Can I use Gericare Hydrocortisone while pregnant or nursing?

Consult a doctor before using this product if you are nursing, as there is a potential for excretion in breast milk and effects on a nursing infant are not well studied.

What precautions should I take when using this product?

Avoid contact with the eyes, do not exceed the recommended dosage, and keep out of reach of children. If swallowed, seek medical help immediately.

What should I do if I experience rectal bleeding?

Discontinue use immediately and consult a doctor if rectal bleeding occurs.

How should I store Gericare Hydrocortisone?

Store at controlled room temperature between 20°-25°C (68°-77°F) and avoid excessive heat and humidity.

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

Gericare Hydrocortisone is a pharmaceutical formulation containing 0.9 grams of hydrocortisone. It is classified under the Center for Drug Evaluation and Research (CDER). The product is designed for medical use, adhering to regulatory standards for safety and efficacy.

Uses and Indications

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

Limitations of Use: Other uses of this product should be undertaken only under the advice and supervision of a healthcare professional.

Dosage and Administration

For the treatment of itching, skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the product to the affected area no more than 3 to 4 times daily. It is advised that children under 2 years of age should not use this product without consulting a physician.

In cases of external and anal itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The product should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Treatment of diaper rash should only be undertaken after consulting a doctor.

  • Concurrent use with any other hydrocortisone product is contraindicated unless a doctor has been consulted.

  • Patients presenting with vaginal discharge should seek medical advice prior to use.

Additionally, if any of the following conditions occur, discontinue use and consult a healthcare professional:

  • Worsening of the condition or persistence of symptoms beyond 7 days.

  • Symptoms that resolve and then reappear within a few days.

  • Occurrence of rectal bleeding.

It is advised to avoid contact with the eyes and not to exceed the recommended daily dosage unless directed by a healthcare provider. This product should not be administered rectally using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of the 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 under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. Additionally, patients should refrain from using any other hydrocortisone products unless specifically directed by a healthcare provider. Rectal bleeding is another critical reason to stop using this product and seek medical advice promptly.

In cases of ingestion, it is essential to obtain 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, symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days. Additionally, patients should stop using this product and refrain from starting any other hydrocortisone product unless directed by a doctor. In the event of rectal bleeding, immediate medical attention is necessary.

Drug Interactions

The concurrent use of this product with any other hydrocortisone formulation is contraindicated unless a healthcare professional has been consulted. It is imperative to discontinue the use of this product and refrain from initiating any other hydrocortisone products without explicit direction from a physician.

No specific drug or laboratory test interactions have been identified in the available data.

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 use the medication for itching, skin irritation, inflammation, and rashes by applying it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the medication is not recommended, and consultation with a doctor is advised. Additionally, for children under 12 years of age, it is recommended to seek medical advice before 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Hydrocortisone 1% cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider during pregnancy.

Lactation

Nursing 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 absence of data regarding 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be maintained until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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.

For patients using this product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Additionally, patients should be informed that they should not use this product in conjunction with any other hydrocortisone product unless they have first consulted a doctor.

Patients experiencing vaginal discharge should also be advised to consult a doctor. Healthcare providers should instruct patients to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

It is crucial to inform patients to discontinue use of this product and refrain from starting any other hydrocortisone product unless directed by a doctor, especially if rectal bleeding occurs. Patients should be cautioned to avoid contact with the eyes while using this product.

Healthcare providers should emphasize the importance of not exceeding the recommended daily dosage unless directed by a doctor. Furthermore, patients should be advised against inserting this product into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature of 20°-25°C (68°-77°F). It is important to avoid exposure to excessive heat and humidity 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 both adults and children aged 2 years and older. For adults specifically experiencing external and anal itching, the same application frequency applies to the affected area. 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 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.