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Rexall Anti Itch

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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 2010
Label revision date
October 3, 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 2010
Label revision date
October 3, 2024
Manufacturer
Dolgencorp, LLC
Registration number
M017
NDC root
55910-225
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

1% Hydrocortisone is a maximum strength anti-itch cream designed to provide intensive relief for various skin irritations. It works by temporarily relieving itching associated with minor skin issues such as eczema, psoriasis, poison ivy, insect bites, and reactions to soaps or cosmetics. This cream also helps soothe external anal and genital itching, making it a versatile option for managing discomfort.

In addition to its anti-itch properties, 1% Hydrocortisone contains antioxidants, chamomile, and aloe, which contribute to its moisturizing effects, clinically proven to last for 24 hours. This makes it a supportive choice for healing and comfort in your skin care routine.

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 like eczema, psoriasis, and reactions to plants such as poison ivy, oak, or sumac. It also helps soothe 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 advice 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 using this treatment.

For external itching in 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or in the genital area if you have a vaginal discharge without consulting a doctor first. Additionally, when using this product, make sure to avoid contact with your eyes. Always follow the directions provided and do not exceed the recommended dosage unless your doctor advises you to do so. Lastly, do not insert the product 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 be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. 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 it for diaper rash or in the genital area if you have a vaginal discharge without first asking a doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the directions provided and do not use more than recommended unless directed by a healthcare professional.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes or in the genital area if you have a vaginal discharge—consult your doctor in these cases. When using the product, be careful not to get it in your eyes, and do not exceed the recommended dosage unless directed by your doctor. It's important not to insert 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. Additionally, if you experience rectal bleeding, seek medical advice immediately. Always keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help right away.

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 cream during pregnancy has not been established. Therefore, it is not recommended to use this product unless your healthcare provider specifically advises you to do so. There may be potential risks to your fetus, so consulting with your doctor before using hydrocortisone cream is essential.

Additionally, if you do receive a recommendation to use it, be aware that dosage adjustments may be necessary. Always follow your healthcare provider's guidance and use this product only under their supervision to ensure the safety of both 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 if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

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 this treatment.

For external anal and genital itching, it's recommended that you speak with a doctor if your child is under 12 years old. 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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, it’s essential to 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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

Additional Information

You can use this medication to relieve itching caused by skin irritation, inflammation, and rashes. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're dealing with external anal and genital itching, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication, also no more than 3 to 4 times daily.

FAQ

What is 1% Hydrocortisone used for?

1% Hydrocortisone is an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, psoriasis, and insect bites.

How should I use 1% Hydrocortisone?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, clean the area first, then apply the cream.

Are there any precautions for using 1% Hydrocortisone?

Yes, avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if symptoms persist for more than 7 days.

Can I use 1% Hydrocortisone during pregnancy?

The safety of hydrocortisone cream during pregnancy has not been established. It is recommended to use it only under the advice and supervision of a healthcare provider.

What should I do if I experience side effects?

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

Is 1% Hydrocortisone safe for children?

Children under 2 years of age should not use this product unless directed by a doctor. For children under 12 years, consult a doctor for external anal and genital itching.

What should I avoid while using 1% Hydrocortisone?

Avoid using it for diaper rash, in the genital area if you have a vaginal discharge, and do not apply it more than directed unless advised by a doctor.

How should I store 1% Hydrocortisone?

Store the cream at 20°-25°C (68°-77°F) to maintain its effectiveness.

Packaging Info

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

Packaging configurations for Rexall Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation contains 1% hydrocortisone, designed as an anti-itch cream. It features an intensive healing formula enriched with antioxidants, chamomile, and aloe. The product is indicated for the relief of dry, itchy skin, rashes, insect bites, eczema, psoriasis, and associated inflammation, irritation, and redness. Each container has a net weight of 1 ounce (28 grams) and is clinically proven to provide 24-hour moisturization.

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, it 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 following dosing guidelines are recommended:

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable 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 medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, it should not be applied in the genital area if there is a vaginal discharge, and a doctor 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 healthcare provider. Furthermore, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for such conditions. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a consultation with a healthcare provider is recommended.

When using this product, it is imperative to avoid contact with the eyes. Patients should be instructed not to exceed the recommended dosage unless directed by a physician. Furthermore, the product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients must be advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is also crucial to refrain from using any other hydrocortisone products without prior consultation with a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

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

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

While using this product, patients should take care to 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 healthcare professional. Additionally, the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, immediate medical attention should be sought.

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 without delay.

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 Rexall Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Rexall Anti Itch.
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, use is not recommended without consulting a doctor.

In cases of external anal and genital itching, it is advised that children under 12 years of age consult a doctor prior to 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

The safety of hydrocortisone cream during pregnancy has not been established. The use of this product is not recommended during pregnancy unless directed by a healthcare provider. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a doctor before use.

Dosage adjustments may be necessary, and medical advice should be sought to determine the appropriate use during pregnancy. Pregnant women should use this product only under the advice and supervision of a healthcare professional to ensure the safety of both the mother and the developing fetus.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 these contexts.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. Additionally, healthcare providers should caution patients against using the product in the genital area if they have a vaginal discharge, and to seek medical advice in such cases.

Patients must be advised 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 instructed not to begin the use of any other hydrocortisone product without first consulting a doctor.

It is important to inform patients to stop using the product and seek medical attention if they experience rectal bleeding. While using this product, patients should be reminded to avoid contact with the eyes.

Healthcare providers should emphasize that patients must not exceed the recommended dosage unless directed by a doctor. 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 package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. 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, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application. This should also be done no more than 3 to 4 times daily.

Drug Information (PDF)

This file contains official product information for Rexall 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 Rexall 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.