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Hydrocortisone Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 0.01 g/1 g
Other brand names
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 2020
Label revision date
December 13, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/1 g
Other brand names
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 2020
Label revision date
December 13, 2020
Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Registration number
part348
NDC root
47046-157
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 Anti-Itch Cream is a topical medication designed to provide temporary relief from itching associated with minor skin irritations and rashes. You can use it for various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. It may also help alleviate itching caused by soaps, detergents, cosmetics, jewelry, and external genital areas.

This cream works by reducing inflammation and soothing the skin, helping to relieve discomfort. However, if you find that you need to use it for more than seven days, it's important to consult with a doctor for guidance.

Uses

You can use this product for the temporary relief of itching caused by various minor skin irritations and rashes. This includes conditions like eczema, seborrheic dermatitis, and psoriasis, as well as reactions to insect bites and plants such as poison ivy, oak, and sumac. It can also help with itching related to soaps, detergents, cosmetics, jewelry, and external areas like the genital and anal regions.

If you find that you need to use this product for more than seven days, it's important to consult with a 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 important to consult a doctor before use.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, you can apply the medication up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please check with a doctor for guidance.

What to Avoid

It's important to use this product safely to avoid potential complications. You should not use it in the genital area if you have a vaginal discharge. Additionally, make sure to follow the dosage instructions carefully—do not use more than directed unless your doctor advises otherwise. Avoid inserting the product directly into the rectum using fingers or any devices.

If your condition worsens, 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. Also, refrain from using any other hydrocortisone products without medical advice. Lastly, be cautious to keep the product away from your eyes.

Side Effects

When using this product, it's important to remember that it is 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 they improve and then return within a few days. Additionally, if you experience rectal bleeding, seek medical advice immediately. Before starting any other hydrocortisone product, make sure to talk to your doctor.

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 immediately. If you have a vaginal discharge, do not use this product in the genital area, and consult your doctor for diaper rash treatment.

You should stop using this product and call your doctor if your condition worsens, if symptoms last more than 7 days, if they improve and then return within a few days, or if you experience rectal bleeding. Additionally, do not start using any other hydrocortisone product without first consulting your doctor.

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

You can use hydrocortisone cream during pregnancy without specific warnings or precautions mentioned in the information provided. There are no indications that this cream is contraindicated (not recommended) for pregnant individuals, nor are there any known risks to the fetus associated with its use. Additionally, you do not need to make any dosage adjustments or take special precautions while using this product during your pregnancy. However, it's always a good idea to consult with your healthcare provider before starting any new medication or treatment.

Lactation Use

You can use hydrocortisone cream while breastfeeding without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or any risks to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about its use while breastfeeding.

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 use.

For external anal and genital itching, adults should clean the area with mild soap and water, then gently dry it before applying the treatment. If your child is under 12 years old, please ask a doctor for guidance. Always prioritize your child's safety and consult a healthcare professional when in doubt.

Geriatric Use

While there is no specific information about the use of Hydrocortisone Anti-Itch Cream in older adults, it's important to approach its use with care. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide guidance tailored to your individual health needs and any other medications you may be taking.

If you are caring for an older adult, be mindful of their overall health and any potential skin sensitivities. Always follow the instructions provided by your healthcare provider or the product label to ensure safe and effective use.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how it should be managed in the context of liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help you understand how to manage your condition while considering any medications you may be taking.

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 at a temperature between 20ºC to 25ºC (68ºF to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device. Additionally, you can find important information such as the lot number and expiration date printed on the crimp of the tube, so be sure to check this before use.

When handling the product, always do so with care to maintain a sterile environment (a clean area free from germs) and avoid any contamination. Following these guidelines will help ensure your safety and the proper functioning of the device.

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 specific issues like external anal and genital itching, adults can also use it in the same manner. Always follow the recommended frequency to ensure safe and effective use.

FAQ

What is Hydrocortisone Anti-Itch Cream used for?

Hydrocortisone Anti-Itch Cream provides temporary relief from itching associated with minor skin irritations and rashes, including conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone Anti-Itch 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.

What should I do if my condition worsens?

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

Can I use this cream if I have a vaginal discharge?

No, do not use Hydrocortisone Anti-Itch Cream in the genital area if you have a vaginal discharge.

Is it safe to use Hydrocortisone Anti-Itch Cream during pregnancy?

The insert does not provide specific warnings or contraindications regarding the use of this cream during pregnancy.

What should I do if I accidentally swallow the cream?

If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store Hydrocortisone Anti-Itch Cream?

Store the cream at a temperature between 20ºC to 25ºC (68ºF to 77ºF).

Packaging Info

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

Packaging configurations for Hydrocortisone Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone Anti-Itch Cream is a topical formulation designed to alleviate itching and inflammation. The product is presented in a net weight of 0.5 ounces (14 grams).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, seborrheic dermatitis, psoriasis, insect bites, and contact with poison ivy, oak, or sumac. It is also effective for itching caused by soaps, detergents, cosmetics, jewelry, and external genital, feminine, and anal areas.

Limitations of use include that any other applications or the use of this product for more than 7 days should be undertaken only under the advice and supervision of a healthcare professional.

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 that, when practical, the affected area be cleaned with mild soap and water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should 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 prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application to the genital area is not recommended in patients with vaginal discharge due to the potential for exacerbating the condition.

  • The product should not be administered rectally using fingers or any mechanical device or applicator, as this may lead to injury or complications.

  • Patients should not exceed the recommended dosage unless directed by a healthcare professional.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare provider should be consulted. Rectal bleeding is also a reason to stop use and seek medical advice. Care should be taken to avoid contact with the eyes.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed when using this product. It is contraindicated for use in the genital area if there is a vaginal discharge present. Additionally, for the treatment of diaper rash, consultation with a healthcare professional is recommended prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if rectal bleeding is observed. Patients should also be cautioned against initiating the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if rectal bleeding occurs. It is advised that patients do not initiate the use of any other hydrocortisone product without first consulting a healthcare professional.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Hydrocortisone Anti-Itch.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients 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 doctor prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application. For children under 12 years of age, consultation with a doctor is recommended before use.

Geriatric Use

There is no specific information regarding the use of Hydrocortisone Anti-Itch Cream 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 efficacy and potential adverse effects is recommended in this population, given the lack of targeted data.

Pregnancy

Hydrocortisone cream is not associated with specific warnings or precautions for use during pregnancy. The prescribing information does not indicate any contraindications for pregnant patients or outline any risks to the fetus related to its use. Additionally, there are no recommended dosage modifications or special precautions for individuals who are pregnant. As with any medication, healthcare professionals should weigh the benefits against potential risks when considering the use of hydrocortisone cream in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, the prescribing information does not provide statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, taking into account the absence of documented concerns.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 insert text.

Patient Counseling

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

Patients should be informed not to use the product in the genital area if they have a vaginal discharge. It is important for patients to consult a doctor regarding the treatment of diaper rash and to ask for guidance before using the product in such cases.

Patients should be instructed to stop using the product 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. Additionally, patients should not begin using any other hydrocortisone product without first consulting a doctor. They should also seek medical attention if rectal bleeding occurs.

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

Storage and Handling

The product is supplied in a configuration that includes a tube, with the Lot Number and Expiration Date indicated on the crimp of the tube.

It is essential to store the product at a temperature range of 20ºC to 25ºC (68ºF to 77ºF) to ensure its stability and efficacy. Proper handling and storage conditions must be maintained to preserve the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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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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.