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Freds Hydrocortisone

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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 2018
Label revision date
July 16, 2025
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 2018
Label revision date
July 16, 2025
Manufacturer
FRED'S, INC.
Registration number
M017
NDC root
55315-182
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

Hydrocortisone is a 1% cream that is primarily used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes. This includes conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac, as well as itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it can help alleviate external anal and genital itching.

This cream not only provides relief from itching but also moisturizes the skin, as it is enriched with Aloe and vitamins A, D, and E. It is important to use Hydrocortisone as directed, and for any other uses, you should consult with a doctor.

Uses

This product is designed to help you find relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It’s also effective for soothing itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to skin irritations, this product can temporarily relieve itching in the external anal and genital areas. If you have other uses in mind, it's best to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from 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 best to consult a doctor before using it.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it 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 is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash—please consult your doctor in these cases. Additionally, avoid contact with your eyes, and do not exceed the recommended dosage unless your doctor advises otherwise. Never insert the medication directly into the rectum using your fingers or any device.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, and do not apply it directly to the rectum using fingers or any devices. If you notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor.

Additionally, do not use this product in the genital area if you have a vaginal discharge or for treating diaper rash without first consulting a healthcare professional. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if it is swallowed, get medical help or contact a Poison Control Center right away.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

You can use hydrocortisone cream during pregnancy, as there are no specific warnings, precautions, or dosage changes mentioned in the product information. The insert does not indicate that the cream is contraindicated (not recommended) for pregnant individuals, nor does it highlight any risks to the fetus associated with its use. However, since there are no specific recommendations for pregnant individuals, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that the information available does not provide clear insights into how breastfeeding may be affected or any potential risks involved.

If you have concerns about breastfeeding while taking medication or any other health-related questions, it's always best to consult with your healthcare provider for personalized advice. They can help you understand any implications for you and your baby.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment 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 to consult a doctor before using the product.

For external anal and genital itching, adults can also apply the treatment 3 to 4 times daily. But for children under 12 years, you should seek advice from a doctor before use. Always prioritize your child's safety and consult a healthcare professional if you have any concerns.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25° C (68° to 77° F). It's important to check the carton or tube crimp for the lot number and expiration date, as this information is crucial for tracking the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any questions about disposal or specific safety measures, please refer to the guidelines provided with your product.

Additional Information

For treating itching caused by skin irritation, inflammation, and 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. If you are dealing with external anal and genital itching, adults should also apply it to the affected area no more than 3 to 4 times daily. Always follow these guidelines to ensure safe and effective use.

FAQ

What is Hydrocortisone cream used for?

Hydrocortisone cream is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone cream?

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, consult a doctor.

Are there any precautions I should take when using this cream?

Avoid contact with eyes, do not use more than directed unless advised by a doctor, and do not apply directly into the rectum.

Can I use Hydrocortisone cream for diaper rash?

No, do not use Hydrocortisone cream for the treatment of diaper rash; consult a doctor instead.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is Hydrocortisone cream safe to use during pregnancy?

The insert does not provide specific information regarding the use of Hydrocortisone cream during pregnancy, so consult your doctor for advice.

What should I do if I accidentally swallow the cream?

If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage conditions for Hydrocortisone cream?

Store Hydrocortisone cream at 20° to 25° C (68° to 77° F).

Packaging Info

Below are the non-prescription pack sizes of Freds Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freds Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Freds Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Hydrocortisone is a 1% cream formulation designed for topical application. It serves as an antipruritic agent, providing relief from itching and rashes associated with various skin conditions, including dry, itchy skin, skin irritation, eczema, and psoriasis. The cream is enriched with aloe and contains a total of 12 moisturizers, which aid in hydrating the skin while alleviating discomfort. Additionally, the formulation is fortified with vitamins A, D, and E, contributing to its skin-nourishing properties. Each container has a net weight of 1 oz (28.4 g).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this drug provides temporary relief for external anal and genital itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication 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 external anal and genital 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. The medication 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 also recommended before use.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the genital area if they are experiencing vaginal discharge; consultation with a physician is recommended in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior medical consultation.

Healthcare providers should instruct patients to avoid contact with the eyes while using this product. It is crucial that patients adhere strictly to the recommended dosage and refrain from exceeding the directed amount unless specifically instructed to do so by a healthcare professional. Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated.

Patients should be advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Furthermore, patients should not initiate the use of any other hydrocortisone product without consulting a physician. In the event of rectal bleeding, immediate medical consultation is necessary.

To ensure safety, this product must be kept out of reach of children. In cases of accidental ingestion, it is essential to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to 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. It is also crucial to seek medical advice if rectal bleeding occurs.

This product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Freds Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freds Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults may apply the medication to the affected area up to 3 to 4 times daily. However, for children under 12 years of age, it is recommended to seek medical advice before application.

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 warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus associated with its use during this period. Additionally, there are no specific recommendations provided for women of childbearing potential regarding the use of hydrocortisone cream during pregnancy. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in pregnant patients.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 drug. 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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition will guide further therapeutic measures.

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.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: skin irritation, allergic reactions, and contact dermatitis. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to communicate that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be cautioned against starting any other hydrocortisone product without first consulting a healthcare professional.

If patients experience rectal bleeding, they should stop using the product and seek medical advice promptly.

While using this product, patients should be advised to avoid contact with their eyes. They should also be instructed not to exceed the recommended dosage unless directed by a healthcare provider. Furthermore, patients should be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled temperature range of 20° to 25° C (68° to 77° F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date, which are essential for tracking and inventory management. Proper handling and storage conditions are crucial to maintain the integrity of the product.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, as well as external anal and genital itching, patients aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. This dosing guideline applies to both adults and children for the specified conditions. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Freds 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 Freds 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.

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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.