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Aosi Healthcare

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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 2024
Label revision date
September 25, 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 2024
Label revision date
September 25, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-054
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

You may find this product helpful for the temporary relief of itching caused by minor irritations and rashes. It is designed to soothe discomfort and provide a sense of relief. However, for any other uses, it is important to consult with a doctor to ensure safety and effectiveness.

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) or nonteratogenic effects associated with this product. Always prioritize your health and safety by following professional medical advice.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if your child is under 2 years old, it’s important not to use this medication. Always consult with a healthcare professional if you have any questions or concerns about its use.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, please contact a Poison Control Center immediately for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, 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 diaper rashes and consult your doctor if you have any concerns. It's important to keep this product out of reach of children. If a child accidentally swallows it, contact a Poison Control Center immediately.

While there are no specific laboratory tests or emergency medical help instructions provided, always prioritize your safety. If you experience any unusual reactions or have questions about its use, stop using the product and reach out to your doctor for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication. 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

Remember, even if no interactions are currently noted, your health can change, and new information may arise. Regular discussions with your provider can help you stay informed and safe.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. This helps maintain its effectiveness and safety. Once you open the product, be sure to discard it after use to prevent any potential contamination or degradation. Following these simple guidelines will help you use the product safely and effectively.

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 are no additional details 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.

How should I apply this product?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Do not use it on children under 2 years of age.

Are there any contraindications for this product?

No contraindications are listed for this product.

What should I do if this product is swallowed?

Keep this product out of reach of children. If swallowed, contact a Poison Control Center right away.

Can I use this product for diaper rash?

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

Is this product safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided, so consult a doctor before use.

What about nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

How should I store this product?

Store at room temperature, protect from light, and discard after opening.

Packaging Info

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

Packaging configurations for Aosi Healthcare.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone is a corticosteroid with a chemical name of hydrocortisone. It appears as a white to off-white crystalline powder. The formulation includes inactive ingredients such as microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. Hydrocortisone is packaged in bottles containing 30 tablets.

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.

The product is not recommended for use in children under 2 years of age. Healthcare professionals should advise caregivers accordingly to prevent misuse in this age group.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event of accidental swallowing, immediate 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 treatment options in such cases.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate contact with a Poison Control Center is essential to ensure proper management and care.

No specific laboratory tests are recommended for monitoring during the use of this product, as no information has been provided in the insert regarding such tests.

Healthcare professionals should remain vigilant and advise patients to seek emergency medical assistance if any severe reactions occur. Additionally, patients should be instructed to discontinue use and contact their healthcare provider if they experience any adverse effects or if their condition does not improve.

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

No drug interactions have been identified for the product, indicating that it does not exhibit significant pharmacodynamic or pharmacokinetic interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Aosi Healthcare.
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

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

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

Additionally, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent. Consultation with a poison control center or a medical toxicologist is recommended for guidance on specific management strategies tailored to the individual case.

Overall, vigilance and prompt intervention are critical in managing potential overdosage situations effectively.

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 medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should contact a Poison Control Center immediately for guidance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at room temperature, away from direct light to maintain its efficacy. Once opened, the product must be discarded to ensure safety and effectiveness.

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 Aosi Healthcare, 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 Aosi Healthcare, 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.