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Atopalm Maximum Strength Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Ointment
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
November 9, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Ointment
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
November 9, 2011
Manufacturer
NeoPharm Co. , Ltd.
Registration number
part348
NDC root
51141-6010
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 Maximum Strength Anti-Itch Ointment is a topical treatment designed to provide temporary relief from itching associated with various minor skin irritations, such as eczema, insect bites, and rashes caused by poison ivy, poison oak, or poison sumac. It contains hydrocortisone (a type of medication that reduces inflammation and itching) at a strength of 1%, and utilizes a patented moisturizing technology to help soothe the skin.

This ointment is available without a prescription and is intended for external use only. It can also be used for conditions like seborrheic dermatitis, psoriasis, and external genital and anal itching. However, it is important to consult a doctor for any other uses or if symptoms persist.

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 itching from soaps, detergents, seborrheic dermatitis, psoriasis, and external genital or 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, it’s best to start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. You can also use toilet tissue or a soft cloth to pat or blot the area before applying the medication. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance before use.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or external genital itching if you have a vaginal discharge—please consult a doctor in these cases. Additionally, avoid contact with your eyes and do not start using any other hydrocortisone product without first consulting your doctor.

When using this product for external anal itching, make sure to follow the recommended dosage and do not exceed it unless directed by a doctor. If you experience any bleeding, seek medical attention immediately. Lastly, never insert this product into the rectum using your fingers or any mechanical device. Your safety is paramount, so always follow these guidelines closely.

Side Effects

This product is intended 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 your symptoms improve and then return within a few days. It's important to pay attention to these signs to ensure your health and safety.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas of your body. It's important to keep this product out of reach of children to prevent accidental ingestion or misuse.

If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, you should stop using the product and contact your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

It's important to be cautious when considering treatments during pregnancy. If you're dealing with diaper rash or external genital itching, it's best to consult your doctor instead of using over-the-counter products. Additionally, if you notice any vaginal discharge, seek medical advice before proceeding with any treatment.

For children under 2 years old, you should not use these treatments without consulting a doctor. If the issue involves external anal itching in children under 12, it's also advisable to talk to a healthcare professional before using any products. Always prioritize safety and seek guidance from your doctor when it comes to treating any conditions during pregnancy or for young children.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor.

For children under 12 years who are experiencing external anal itching, you should also consult a doctor before using this treatment. 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor 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 plan.

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 ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

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

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

Additional Information

No further information is available.

FAQ

What is ATOPALM Maximum Strength Anti-Itch Ointment used for?

It is used for the 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 product?

Children under 2 years of age should not use this product without consulting a doctor. Additionally, it should not be used for diaper rash or external genital itching if there is a vaginal discharge.

How should I apply ATOPALM Maximum Strength Anti-Itch Ointment?

Adults and children 2 years and older should apply it to the affected area no more than 3 to 4 times daily.

What precautions should I take when using this ointment?

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

What should I do if my condition worsens or does not improve?

Stop using the product and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store this ointment?

Store ATOPALM Maximum Strength Anti-Itch Ointment at 20° – 25°C (68° – 77°F).

What is the active ingredient in this ointment?

The active ingredient is hydrocortisone 1%, which helps relieve itching.

Is this ointment safe for nursing mothers?

No specific information is provided regarding the use of this ointment by nursing mothers.

Packaging Info

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

Packaging configurations for Atopalm Maximum Strength Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No Description information provided.

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, 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.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the product to the affected area no more than 3 to 4 times daily. For external anal itching in adults, it is recommended to cleanse the affected area with mild soap and warm water, rinsing thoroughly, or by patting or blotting with toilet tissue or a soft cloth prior to application.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor before use.

Contraindications

The use of this product is contraindicated in the following situations:

  • It should not be used for the treatment of diaper rash; consultation with a doctor is advised.

  • The product is contraindicated for external genital itching in the presence of vaginal discharge; a doctor should be consulted.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • The initiation of any other hydrocortisone product should only occur after consulting a doctor.

  • For external anal itching, the recommended daily dosage should not be exceeded unless directed by a doctor. In cases of bleeding, prompt consultation with a doctor is necessary.

  • The product must not be inserted into the rectum using fingers or any mechanical device for application.

Warnings and Precautions

For external use only. It is imperative that this product is applied solely to the designated areas of the skin and not ingested or applied to mucous membranes.

General precautions should be observed to ensure safety. This product must be kept out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate management and to rule out any underlying conditions that may require further evaluation.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Atopalm Maximum Strength Anti-Itch.
Details

Pediatric Use

Pediatric patients aged 2 years and older may 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, and a consultation with a doctor is advised. Additionally, for external anal itching, it is important for children under 12 years of age to consult a doctor before 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

Pregnant patients should be advised against using this medication for the treatment of diaper rash and external genital itching. If a vaginal discharge is present, consultation with a healthcare provider is recommended. The safety of this medication in pregnant women has not been established, and its use in children under 2 years of age is contraindicated; therefore, pregnant patients should consult a doctor before use. Additionally, for external anal itching, children under 12 years of age should also seek medical advice prior to use. Caution is advised when considering this medication during pregnancy, and healthcare providers should evaluate the potential risks and benefits for each individual patient.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 of these patients.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion or misuse. For patients seeking treatment for diaper rash, it is important to recommend consulting a doctor prior to use to ensure appropriate care.

In cases of external genital itching, healthcare providers should instruct patients to seek medical advice if they experience vaginal discharge. 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 clear up and then recur within a few days.

When using this product, patients must be cautioned to avoid contact with the eyes to prevent irritation. Additionally, healthcare providers should emphasize that patients should not begin using any other hydrocortisone product without prior consultation with a doctor.

For those experiencing external anal itching, it is crucial to advise patients not to exceed the recommended daily dosage unless directed by a healthcare professional. In the event of bleeding, patients should be instructed to consult a doctor promptly. Furthermore, patients must be warned against inserting this product into the rectum using fingers or any mechanical device for application, as this could lead to complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Healthcare professionals are advised to check the end of the carton or the tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Atopalm Maximum Strength 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 Atopalm Maximum Strength 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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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.