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Atopalm Moisturizing Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 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 2011
Label revision date
June 9, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 2011
Label revision date
June 9, 2015
Manufacturer
NeoPharm Co. , Ltd.
Registration number
part348
NDC root
51141-6000
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

ATOPALM MOISTURIZING HYDROCORTISONE CREAM is a maximum strength cream that contains 1% hydrocortisone, designed to provide fast relief from itching and redness associated with various skin conditions. This over-the-counter medication helps temporarily alleviate symptoms caused by dry skin, eczema, psoriasis, seborrheic dermatitis, insect bites, and reactions to plants like poison ivy, as well as irritations from soaps, detergents, and jewelry.

The cream works by reducing inflammation and soothing irritated skin, making it a helpful option for those experiencing minor skin irritations and rashes. With its patented MLE Technology, ATOPALM aims to promote visibly healthier-looking skin while offering quick relief from discomfort.

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, or poison sumac. It can also help soothe irritation from soaps, detergents, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

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 children under 2 years old, it’s important not to use this product without first consulting a doctor.

If you are dealing with external anal itching, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After that, make sure to dry the area carefully by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person experiencing this issue is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. Do not use it for treating diaper rash, and if you experience external genital itching or have a vaginal discharge, please consult your doctor. Always follow the recommended daily dosage and do not exceed it unless directed by your healthcare provider.

Additionally, avoid starting any other hydrocortisone products without first consulting your doctor. Never apply this product rectally using your fingers or any device. If you need to stop using this medication, do not start any other hydrocortisone products without medical advice. Your health and safety are paramount, so please reach out to your healthcare provider with any questions or concerns.

Side Effects

You should only use this product on the skin and not for any other purposes. If your condition worsens, or if symptoms last more than 7 days or return shortly after treatment, stop using it and consult your doctor. It's important not to use any other hydrocortisone products without your doctor's advice, and you should not exceed the recommended dosage unless directed by a healthcare professional.

Additionally, do not use this product for diaper rash. If you experience external genital itching or have vaginal discharge, please consult your doctor for appropriate guidance.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms return shortly after cleaning up. Additionally, do not use any other hydrocortisone products without first talking to your doctor, and make sure not to exceed the recommended daily dosage unless directed by a healthcare professional.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms detailed for this situation, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel concerned, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely intervention can be crucial.

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. There may be potential risks to your fetus, so it's crucial to consult your doctor before using this medication. Your healthcare provider can help determine if hydrocortisone is appropriate for you and may recommend dosage adjustments tailored to your specific situation. Always seek professional guidance to ensure the best care for you and your baby.

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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children experiencing external anal itching, you should also consult a doctor if they are under 12 years of age.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow your healthcare provider's advice to ensure the safety and well-being of your child.

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 for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver condition and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication if you are already using any other hydrocortisone product. This is to ensure that you avoid any potential interactions that could affect how well your treatments work or increase the risk of side effects.

While there are no specific interactions with laboratory tests mentioned, discussing all medications and tests with your healthcare provider is crucial. They can help you understand how different treatments may work together and ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it in a stable environment, away from extreme heat or cold. Additionally, you should check the end of the carton or the crimp of the tube 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 to maintain its integrity. If you have any questions about disposal or specific safety measures, please refer to the product's packaging or consult a healthcare professional for guidance.

Additional Information

For adults and children aged 2 years and older, you can apply the product to the affected area up to 3 to 4 times a day. If you are caring for a child under 2 years old, do not use this product without consulting a doctor first.

If you are dealing with external anal itching, it's important to first cleanse the area with mild soap and warm water, then rinse thoroughly. After that, gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying the product. For children under 12 years experiencing this issue, it's best to consult a doctor.

FAQ

What is ATOPALM MOISTURIZING HYDROCORTISONE CREAM used for?

It is used for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to conditions like eczema, insect bites, and psoriasis.

How often can I apply this cream?

Adults and children 2 years of age and older can apply it to the affected area not more than 3 to 4 times daily.

Is this product safe for children under 2 years of age?

No, do not use this product on children under 2 years of age without consulting a doctor.

What should I do if my condition worsens?

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

Can I use this cream for diaper rash?

No, do not use it for the treatment of diaper rash. Consult a doctor for external genital itching.

What precautions should I take when using this product?

Avoid contact with the eyes, do not exceed the recommended dosage, and do not use any other hydrocortisone product without consulting a doctor.

Is it safe to use this cream during pregnancy?

The safety of hydrocortisone during pregnancy has not been established, so consult a doctor before use.

What should I do if I accidentally swallow this product?

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

How should I store this cream?

Store at room temperature and check the end of the carton or tube crimp for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Atopalm Moisturizing Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This Maximum Strength 1% Hydrocortisone cream, branded as ATOPALM™, is a moisturizing formulation designed to provide temporary relief from itching and redness associated with various skin conditions. The cream incorporates US patented MLE technology, which aids in enhancing skin hydration and appearance. It is indicated for the relief of itch symptoms due to dry skin, psoriasis, seborrheic dermatitis, and rashes. The product is available in a net weight of 1 oz (28.3 g).

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal 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 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 use of this product is not recommended; a consultation with a healthcare professional is advised.

In cases of external anal itching, it is recommended that adults first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by 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

The product is contraindicated for the treatment of diaper rash. Consultation with a healthcare professional is advised for external genital itching or in the presence of vaginal discharge.

Patients should not exceed the recommended daily dosage unless directed by a physician. The initiation of any other hydrocortisone product is contraindicated without prior consultation with a healthcare provider. Additionally, the product should not be administered rectally using fingers or any mechanical device. If the product is used, patients must discontinue use and consult a doctor before starting any other hydrocortisone products.

Warnings and Precautions

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

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should also stop use and seek medical advice. Furthermore, patients are cautioned against the use of any other hydrocortisone products without prior consultation with a healthcare provider. It is essential that the recommended daily dosage is not exceeded unless specifically directed by a physician.

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

Side Effects

Patients should be aware that the product is intended for external use only. It is crucial to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms improve and then recur within a few days, patients should also discontinue use and seek medical advice. It is advised not to exceed the recommended daily dosage unless directed by a healthcare professional.

The product is not indicated for the treatment of diaper rash. Patients experiencing external genital itching or those with vaginal discharge should consult a doctor prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently using any other hydrocortisone formulations. This precaution is essential to avoid potential additive effects or complications associated with hydrocortisone therapy.

No specific drug or laboratory test interactions have been identified in the available data. However, it is advisable to remain vigilant for any unforeseen interactions and to discuss any concerns with a healthcare provider.

Packaging & NDC

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

Packaging configurations for Atopalm Moisturizing Hydrocortisone.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For the treatment of external anal itching, children under 12 years of age should also consult a doctor prior to use.

For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 associated with the use of hydrocortisone; therefore, it is essential that its use is guided by a healthcare professional. Additionally, dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a doctor.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

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.

Patients should be informed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clean up and then recur within a few days. It is important to emphasize that patients should not exceed the recommended daily dosage unless directed by a doctor.

When using this product, patients should be cautioned to avoid contact with the eyes. Additionally, they should not begin the use of any other hydrocortisone products without first consulting a doctor. For those using the product for external anal itching, it is crucial to adhere to the recommended daily dosage and to consult a doctor promptly in the event of bleeding.

Patients should be instructed not to insert this product into the rectum using fingers or any mechanical device for application. It is advisable for patients to ask a doctor or pharmacist before use if they are currently using any other hydrocortisone product.

Finally, healthcare providers should inform patients that this product is not intended for the treatment of diaper rash and that they should consult a doctor for external genital itching or if they experience a vaginal discharge.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy. For traceability, the lot number and expiration date can be found at the end of the carton or on the tube crimp. Special handling requirements are not specified; however, standard precautions should be observed to ensure product integrity.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

Clinicians should counsel patients on proper application techniques for external anal itching. Adults are recommended to cleanse the affected area with mild soap and warm water, rinsing thoroughly, and then gently drying by patting or blotting with toilet tissue or a soft cloth prior to application. Additionally, children under 12 years of age experiencing external anal itching should be advised to consult a doctor.

Drug Information (PDF)

This file contains official product information for Atopalm Moisturizing 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 Atopalm Moisturizing 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.