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Burnx

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 0.025 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
October 24, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.025 g/1 g
Other brand names
Dosage form
Gel
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 2010
Label revision date
October 24, 2017
Manufacturer
Natureplex, LLC
Registration number
part348
NDC root
67234-037
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

Natureplex™ is a topical analgesic gel designed to provide temporary relief from pain associated with minor burns, sunburn, and minor skin irritations. Its active ingredient, lidocaine HCl (a local anesthetic), works by numbing the affected area to help alleviate discomfort.

This product is available in a 1-ounce tube and is also known by the name BurnX™. If you experience minor skin injuries, Natureplex™ may help soothe your pain and promote comfort.

Uses

You can use this medication for the temporary relief of pain caused by minor burns, sunburn, and minor skin irritations. It helps soothe discomfort and provides a sense of relief when your skin is feeling irritated or damaged.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, 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 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.

For children under 2 years of age, it’s important to consult a doctor before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safe and effective treatment.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. It's important to avoid using it in large amounts, especially on raw or blistered skin. If your condition worsens, if symptoms last more than seven days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor. Additionally, if you develop a rash or irritation that persists or worsens, seek medical advice.

If you are pregnant or breastfeeding, it's best 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.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. It's important not to use it for extended periods or in large amounts, especially on raw or blistered skin.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you notice any rash or irritation that persists or worsens, seek medical advice. Always keep this product out of reach of children. If it is swallowed, get medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, which can vary depending on the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 under 2 years old, it's important to consult a doctor before using this medication. 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 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 regarding its use. This means that there are no recommended age-related considerations, dosage adjustments, or safety concerns specifically for elderly patients.

As always, it's important for you or your caregiver to discuss any medications with your healthcare provider, especially if you have any underlying health conditions or are taking other medications. Your doctor can help ensure that any treatment plan is safe and effective for your individual needs.

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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

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 you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health safely.

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 cautious and check the seal on the tube before use. If the seal is punctured or missing, do not use the product, as this could compromise its safety and effectiveness. Always follow these guidelines to ensure safe and proper use.

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. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Natureplex™?

Natureplex™ is a pain-relieving burn gel formulated as a topical analgesic.

What is the active ingredient in Natureplex™?

The active ingredient in Natureplex™ is Lidocaine HCl 2.5%, which helps relieve pain.

What conditions does Natureplex™ treat?

Natureplex™ is indicated for the temporary relief of pain associated with minor burns, sunburn, and minor skin irritations.

How should I use Natureplex™?

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

Are there any contraindications for using Natureplex™?

No specific contraindications are mentioned for Natureplex™.

What should I do if I experience side effects?

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

Can I use Natureplex™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using Natureplex™.

What precautions should I take when using Natureplex™?

Use Natureplex™ for external use only, avoid contact with eyes, and do not use in large quantities over raw surfaces or blistered areas.

What should I do if Natureplex™ is swallowed?

If swallowed, get medical help or contact a Poison Control Center immediately at 800-222-1222.

How should I store Natureplex™?

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

Packaging Info

Below are the non-prescription pack sizes of Burnx (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burnx.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Natureplex™ BurnX™ is a topical analgesic formulated to provide pain relief for burns and sunburns. Each 1 oz (28 g) tube contains lidocaine hydrochloride at a concentration of 2.5%. The product is identified by NDC 67234-037-01 and is specifically designed for external use to alleviate discomfort associated with thermal injuries.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns, sunburn, and minor skin irritations.

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 performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified in the provided data.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. Prolonged use of the product is not recommended, and it should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate adverse effects.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if a rash or irritation develops, persists, or increases, medical advice should be sought promptly.

It is essential to keep the product out of the 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 using this product may experience various adverse reactions. It is important to note that the product is intended for external use only, and contact with the eyes should be avoided. Prolonged use is not recommended, and the product should not be applied in large quantities, especially over raw surfaces or blistered areas.

Patients are advised to discontinue use and consult a healthcare professional 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, if a rash or irritation develops, persists, or increases, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product. Furthermore, the 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 no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Burnx (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burnx.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. 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 regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 800-222-1222 for guidance on the appropriate steps to take.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement necessary management procedures based on the severity of symptoms presented.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be cautioned against using the medication in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if a rash or irritation develops, persists, or increases.

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) to maintain its efficacy. Healthcare professionals should ensure that the seal on the tube is intact; the product must not be used if the seal is punctured or missing. Proper handling and storage conditions are crucial to ensure the product's quality and safety.

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. For children under 2 years of age, consultation with a doctor is advised prior to use. 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 Burnx, 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 Burnx, 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.