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Health Beyond

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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 2025
Label revision date
November 23, 2025
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 2025
Label revision date
November 23, 2025
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-092
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

This medication is designed to provide temporary relief from itching caused by minor irritations and rashes. It can help soothe discomfort and improve your overall comfort during these situations. For any other uses, it's important to consult with a doctor to ensure safe and appropriate application.

Uses

You can use this product for temporary relief from itching caused by minor irritations and rashes. It's important to remember that if you have other uses in mind for this product, you should consult with your doctor first to ensure it's appropriate for your situation.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

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 of your skin. Make sure to do this no more than 3 to 4 times each day. It's important to follow this guideline to ensure safe and effective use.

However, if your child is under 2 years old, you should not use this medication. Always consult with a healthcare professional if you have any questions or concerns about using this treatment for yourself or your child.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

It's important to note that this product is for external use only. You should not use it for treating diaper rash; if you have concerns about diaper rash, please consult a doctor for appropriate advice. Always prioritize your health and safety when using any medication.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. It is important not to use this product for treating diaper rash; if you have questions or concerns, consult your doctor.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

It’s important to be cautious when considering the use of this product during pregnancy. First, ensure that the packaging is intact; do not use it if it has been opened or damaged. If you have any questions about how this product may affect you or your pregnancy, consult your doctor for guidance. Additionally, this product is not recommended for children under 2 years of age, so keep that in mind if you have young children at home. Always prioritize your health and safety by seeking professional advice.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. Currently, there is no specific information available about whether hydrocortisone cream can pass into breast milk or what risks it may pose to your baby. Consulting with your healthcare provider will help ensure that you make the safest choice for both you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 2 years of age. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the 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 your treatment, discussing your full medical history and any other medications is crucial. This ensures that your healthcare provider can give you the best advice tailored to your needs and help avoid any potential issues. Always feel free to ask questions and share any concerns you might have.

Storage and Handling

You can feel confident knowing that there are no specific storage or handling instructions provided for this product. This means you can use it as intended without worrying about special requirements for keeping it safe or effective.

If you have any questions about how to use the product or need further information, don’t hesitate to reach out to your healthcare provider or the manufacturer for guidance. Always ensure you follow general safety practices when handling any medical device.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. However, do not use it on children under 2 years of age. There is no additional information available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is this product used for?

This product is used for temporary relief of itching associated with minor irritations and rashes. Other uses should only be under the advice and supervision of a doctor.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 2 years of age should not use it.

How often can I apply this product?

You can apply this product to the affected area not more than 3 to 4 times daily.

Are there any contraindications for this product?

There are no contraindications listed for this product.

What should I do if this product is swallowed?

If swallowed, you should get medical help or contact a Poison Control Center right away.

Can I use this product for diaper rash?

No, you should not use this product for the treatment of diaper rash. Consult a doctor instead.

Is this product safe for nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is no specific information regarding its safety in breast milk.

What should I do if the packaging is opened or damaged?

Do not use the product if the packaging has been opened or damaged.

What precautions should I take with this product?

Keep this product out of reach of children and use it only for external purposes.

Packaging Info

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

Packaging configurations for Health Beyond.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor irritations and rashes. Other uses of this product should be undertaken only 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 recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

In children under 2 years of age, the product should not be used. Healthcare professionals should advise caregivers to adhere strictly to these guidelines to ensure safety and efficacy.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 appropriate alternatives.

General precautions must be observed to ensure safety. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if they experience any adverse effects or if the product is used for unintended purposes, such as treating diaper rash.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for the treatment of diaper rash; individuals should consult a doctor for appropriate management in such cases.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. However, it is essential for patients to follow the usage guidelines to minimize the risk of adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with 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 Health Beyond (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Health Beyond.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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 product if the packaging has been opened or damaged, as this may compromise the safety and efficacy of the medication. It is essential for healthcare professionals to consult with a doctor regarding any alternative uses of this product during pregnancy. Additionally, this product is not recommended for children under 2 years of age, which may also be a consideration for pregnant patients with young children. The potential risks and benefits should be carefully evaluated in the context of each individual patient's circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is no specific information available regarding the potential for excretion of hydrocortisone cream in breast milk or the associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and a detailed history of substance use.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies and antidotes, if applicable.

  4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

It is imperative for healthcare professionals to familiarize themselves with the specific management protocols for the substances involved in any potential overdose scenario.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is vital to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. However, no specific storage or handling information is provided in the current labeling. It is recommended that healthcare professionals refer to standard storage practices for similar products and ensure that all handling complies with applicable regulations and guidelines.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. It is contraindicated for use in children under 2 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Health Beyond, 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 Health Beyond, 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.

Learn more in our Editorial Policy

Last AI update:

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.