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Dr. Sheffield Hydrocortisone Anti Itch

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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 2007
Label revision date
October 30, 2023
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 2007
Label revision date
October 30, 2023
Manufacturer
Sheffield Pharmaceuticals LLC
Registration number
M017
NDC root
11527-052
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Hydrocortisone 1% Anti-itch Cream is a maximum strength cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used for various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

This cream works by reducing inflammation and alleviating discomfort, making it a helpful option for soothing irritated skin. For any other uses, it's important to consult with a doctor for guidance.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

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 up to 3 to 4 times a day. For best results, especially if you are treating external anal itching, it’s a good idea to first clean the area gently with mild soap and warm water. Make sure to rinse thoroughly or pat the area dry with toilet tissue or a soft cloth before applying the product.

If you have a child under 2 years old, do not use this medication without consulting a doctor. Additionally, if a child under 12 years is experiencing external anal itching, it’s important to speak with a doctor before using this product. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should be aware of several important guidelines when using this product. First, do not use it for treating diaper rash or external genital itching if you have a vaginal discharge; in these cases, it's best to consult a doctor. Additionally, avoid starting any other hydrocortisone product without first speaking to your healthcare provider. It's crucial not to exceed the recommended daily dosage for external genital, feminine, and anal itching unless directed by a doctor. Also, never insert this product into the rectum using fingers or any device.

If your condition worsens, or if symptoms persist for more than 7 days or return shortly after clearing up, stop using the product and consult a doctor before considering any other hydrocortisone treatments. Lastly, be careful to keep the product away from your eyes while using it.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, avoid using this product for diaper rash or external genital itching if you have a vaginal discharge without first consulting a doctor.

Make sure to keep the product away from your eyes and do not exceed the recommended dosage for external genital, feminine, or anal itching unless directed by a doctor. If you experience any bleeding, discontinue use immediately and seek medical advice. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only and should not be used for treating diaper rash or external genital itching if you have a vaginal discharge; please consult your doctor in these cases. While using this product, avoid contact with your eyes and do not use any other hydrocortisone product without first talking to your doctor. If you are treating external genital, feminine, or anal itching, do not exceed the recommended daily dosage unless directed by a doctor. If you experience any bleeding, stop using the product and consult your doctor.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last more than 7 days, or if symptoms clear up and then return within a few days. Remember to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone during pregnancy has not been established. You should consult your doctor before using this medication, as there may be potential risks to your fetus. It's essential to use hydrocortisone only if it is clearly needed and if your healthcare provider believes the benefits outweigh the risks.

Additionally, dosage adjustments may be necessary, so be sure to discuss this with your healthcare provider for proper guidance. Always prioritize your health and the health of your baby by seeking medical advice before starting any new medication.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

If you have a child under 2 years of age, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal itching, please consult a doctor before use to ensure their safety and proper care.

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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. This ensures that you avoid any potential complications or interactions with your current medications. Your doctor can help you understand how different treatments may affect each other and your overall health.

While there are no specific interactions with laboratory tests mentioned, maintaining open communication with your healthcare team about all medications and tests is crucial. This way, you can ensure safe and effective treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20 - 25ºC (68 - 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Hydrocortisone 1% Anti-itch Cream used for?

Hydrocortisone 1% Anti-itch Cream is used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

Who should not use this cream?

Do not use this cream for children under 2 years of age, for diaper rash, or for external genital itching if you have a vaginal discharge without consulting a doctor.

How should I apply Hydrocortisone 1% Anti-itch Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily.

What should I do if my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, stop using the cream and consult a doctor.

Can I use this cream during pregnancy?

The safety of hydrocortisone during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

What precautions should I take when using this cream?

Avoid contact with eyes, do not use other hydrocortisone products without consulting a doctor, and do not exceed the recommended dosage for external genital, feminine, and anal itching.

Where should I store Hydrocortisone 1% Anti-itch Cream?

Store the cream at a controlled room temperature of 20 - 25ºC (68 - 77ºF).

Packaging Info

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

Packaging configurations for Dr. Sheffield Hydrocortisone Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone MAXIMUM STRENGTH is a topical anti-itch cream formulated with 1% hydrocortisone. Each container has a net weight of 1 oz (28 g). This product is manufactured by Dr. Sheffield's under the SHEAF-FIELD™ brand and is produced in the USA.

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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external feminine, genital, and anal itching.

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

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised.

In cases of external anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinsing thoroughly, or patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age experiencing external anal itching, consultation with a healthcare professional is also recommended.

Contraindications

Use of this product is contraindicated in the following situations:

  • Treatment of diaper rash is not recommended; consultation with a healthcare professional is advised.

  • External genital itching should not be treated if accompanied by vaginal discharge; a healthcare professional should be consulted.

  • Initiation of any other hydrocortisone product is contraindicated without prior consultation with a healthcare professional.

  • Exceeding the recommended daily dosage for external genital, feminine, and anal itching is contraindicated unless directed by a healthcare professional.

  • Insertion of this product into the rectum using fingers or any mechanical device or applicator is contraindicated.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or symptoms clear and recur within a few days, discontinue use and consult a healthcare professional before using any other hydrocortisone product. Avoid contact with eyes during use.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate management. Additionally, this product should not be used for external genital itching in the presence of vaginal discharge; a consultation with a healthcare provider is recommended in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Patients should be cautioned against initiating the use of any other hydrocortisone products without prior consultation with a healthcare professional. For indications of external genital, feminine, and anal itching, patients must adhere strictly to the recommended daily dosage unless otherwise directed by a physician. In the event of bleeding, the use of this product should be discontinued immediately, and medical advice should be sought.

Patients should be instructed to stop using the product and consult a healthcare provider if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to refrain from using any other hydrocortisone products unless directed by a doctor.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that this product is for external use only.

Warnings indicate that the product should not be used for the treatment of diaper rash or for external genital itching if a vaginal discharge is present; in such cases, consultation with a doctor is advised. While using this product, patients should avoid contact with the eyes and refrain from initiating the use of any other hydrocortisone product without prior consultation with a healthcare professional. For external genital, feminine, and anal itching, patients should not exceed the recommended daily dosage unless directed by a doctor. In the event of bleeding, patients are advised to stop use and consult a doctor.

Patients should discontinue use and seek medical advice if their 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 recommended that patients do not insert this product into the rectum using fingers or any mechanical device or applicator.

Additionally, it is crucial to keep this product out of reach of children. If swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Packaging configurations for Dr. Sheffield Hydrocortisone Anti Itch.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor for appropriate alternatives. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. In children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, the use of hydrocortisone should be under medical supervision. Dosage adjustments may be necessary, and healthcare providers should be consulted for guidance on appropriate dosing. It is recommended that hydrocortisone be used only if clearly needed, and when the benefits outweigh the risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help or contact a Poison Control Center without delay.

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

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance involved and the severity of the overdosage.

In all cases, timely communication with poison control and adherence to established medical guidelines are recommended to ensure the best possible care for the patient.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 the product for the treatment of diaper rash, it is important to recommend consulting a doctor prior to use. Similarly, for those experiencing external genital itching accompanied by vaginal discharge, a consultation with a healthcare professional is necessary.

Patients should be informed that if their condition worsens, they must stop using the product and consult a doctor. Additionally, if symptoms persist for more than 7 days or if they clear up and then recur within a few days, they should discontinue use and refrain from starting any other hydrocortisone product unless directed by a healthcare provider.

Emphasize the importance of avoiding contact with the eyes. Patients should not begin using any other hydrocortisone product without prior consultation with a doctor. For those using the product for external genital, feminine, and anal itching, it is crucial to adhere to the recommended daily dosage and not exceed it unless directed by a healthcare professional. In the event of bleeding, patients should stop use and seek medical advice.

Finally, instruct patients not to insert this product into the rectum using fingers or any mechanical device or applicator.

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 a controlled room temperature, maintaining a range of 20 to 25ºC (68 to 77ºF). Proper storage conditions are crucial 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 adults and children aged 2 years and older, specifically to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dr. Sheffield Hydrocortisone Anti Itch, 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 Dr. Sheffield Hydrocortisone Anti Itch, 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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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.