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Natureplex Hydrocortisone

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Active ingredient
Hydrocortisone 0.01 g/1 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 2008
Label revision date
February 13, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 0.01 g/1 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 2008
Label revision date
February 13, 2026
Manufacturer
Natureplex, LLC
Registration number
M017
NDC root
67234-010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

Natureplex™ is a maximum strength hydrocortisone cream designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. This includes conditions caused by eczema, insect bites, and contact with plants like poison ivy, poison oak, and poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it can help relieve external anal and genital itching.

With a net weight of 1.5 oz. (28g), Natureplex™ offers fast relief for those uncomfortable skin issues, helping you feel more comfortable in your skin.

Uses

You can use this medication for temporary relief from itching caused by minor skin irritations, inflammation, and rashes. This includes conditions related to eczema, insect bites, and contact with plants like poison ivy, poison oak, and poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, and jewelry.

Additionally, this medication is effective for relieving external itching in the anal and genital areas. If you're experiencing any of these types of itching, this treatment may provide the comfort you need.

Dosage and Administration

If you're dealing with itching from minor skin irritations, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's best to consult a doctor before using the product.

For external itching in the anal and genital areas, adults and children aged 12 and older should first clean the area with mild soap or warm water, rinsing thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, also up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be cautious when using this medication. You should not use it if you have a vaginal discharge; please consult your doctor in this case. Additionally, make sure to follow the recommended daily dosage and avoid exceeding it unless your doctor advises otherwise.

For your safety, do not insert the medication into the rectum using your fingers or any mechanical device or applicator. These precautions help prevent misuse and ensure that you use the medication safely and effectively.

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return shortly after. Additionally, if you experience any bleeding, seek medical advice immediately.

This product is for external use only, and you should avoid contact with your eyes. Do not use it if you have a vaginal discharge without consulting a doctor first. If you are pregnant or breastfeeding, it's best to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away at 800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If you have a vaginal discharge, do not use this product and consult your doctor instead. When using it, make sure to follow the recommended daily dosage and never insert it into the rectum using fingers or any devices.

You should stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you experience any bleeding, seek medical advice. If you are pregnant or breastfeeding, consult a health professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

It's very important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center at 800-222-1222.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is experiencing itching from minor skin irritations, 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 the product.

For external itching in the anal and genital areas, the treatment is suitable for children aged 12 years and older, with the same application frequency of 3 to 4 times daily. If your child is younger than 12, please consult a doctor for guidance. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by 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.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes 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 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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 to 30°C (59 to 86°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the seal on the tube before use. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its integrity.

Additional Information

For treating itching related to minor skin irritations, inflammation, and rashes, you should apply the medication to the affected area no more than 3 to 4 times a day. The same frequency applies for external anal and genital itching.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

FAQ

What is Natureplex™?

Natureplex™ is a maximum strength hydrocortisone cream used for temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions does Natureplex™ help relieve?

It provides relief for itching due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and external anal and genital itching.

How should I use Natureplex™?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2, consult a doctor.

Are there any contraindications for using Natureplex™?

Do not use if you have a vaginal discharge. Consult a doctor if this applies to you.

What should I do if my condition worsens while using Natureplex™?

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

Is Natureplex™ safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What precautions should I take when using Natureplex™?

Avoid contact with eyes, do not exceed the recommended dosage, and do not use fingers or devices to apply it rectally.

How should I store Natureplex™?

Store at 15 to 30°C (59 to 86°F) and do not use if the seal on the tube is broken or missing.

What should I do if Natureplex™ is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 800-222-1222.

Packaging Info

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

Packaging configurations for Natureplex Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Natureplex Hydrocortisone, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, and jewelry. Additionally, it is indicated for the relief of external anal and genital itching.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For the treatment of itching associated with minor skin irritations, inflammation, and rashes, the following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of external anal and genital itching, adults and children aged 12 years and older should first cleanse the affected area with mild soap or warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product. Application should not exceed 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended before use.

Contraindications

Use is contraindicated in patients with a vaginal discharge; consultation with a healthcare professional is advised in such cases.

Exceeding the recommended daily dosage is contraindicated unless directed by a physician.

The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is contraindicated for use in individuals with vaginal discharge; such patients should be instructed to consult a healthcare provider prior to use.

When utilizing this product, it is imperative that patients adhere to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare professional. Additionally, patients must be cautioned against inserting the product into the rectum using fingers, mechanical devices, or applicators, as this may lead to complications.

Patients should be advised to discontinue use and seek medical advice if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, or any occurrence of bleeding.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

This product should be stored 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 at 800-222-1222.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. Patients are advised not to use the product if they have a vaginal discharge and should consult a doctor in such cases.

When using this product, it is crucial not to exceed the recommended daily dosage unless directed by a healthcare professional. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients are instructed to stop 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. The presence of any bleeding also necessitates discontinuation of use and medical consultation.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Natureplex Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product for itching associated with minor skin irritations, inflammation, and rashes, with application to the affected area not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

For external anal and genital itching, the product is indicated for adults and children 12 years of age and older, with the same application frequency of 3 to 4 times daily. Children under 12 years of age should also 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 there is no available data to guide dosing or monitoring in this 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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay; the national hotline can be reached at 800-222-1222.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be informed that this product should not be used if they have a vaginal discharge and should consult a doctor in such cases. They should also be instructed to stop using the product 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. Additionally, patients should be advised to discontinue use and seek medical advice if any bleeding occurs.

While using this product, patients must not exceed the recommended daily dosage unless directed by a healthcare professional. It is also important to inform patients that they should not insert the product into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product at a temperature range of 15 to 30°C (59 to 86°F). Healthcare professionals should ensure that the seal on the tube is intact before use; the product must not be used if the seal is broken or missing. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

For the management of itching associated with minor skin irritations, inflammation, and rashes, as well as external anal and genital itching, patients should apply the product to the affected area no more than 3 to 4 times daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the product out of reach of children; in the event of ingestion, medical assistance should be sought immediately or the Poison Control Center contacted at 800-222-1222.

Drug Information (PDF)

This file contains official product information for Natureplex 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 Natureplex 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.

Learn more in our Editorial Policy

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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.