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Lightning Pain Relief

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Active ingredient
Menthol 40 mg/1 g
Other brand names
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 2019
Label revision date
January 2, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 40 mg/1 g
Other brand names
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 2019
Label revision date
January 2, 2024
Manufacturer
Clinical Resolution Laboratory, Inc.
Registration number
M017
NDC root
63742-013
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 medication helpful for the temporary relief of minor aches and pains in your muscles and joints. It is commonly used for conditions such as simple backache, arthritis, strains, bruises, and sprains. This drug works by providing both cooling and warming sensations to help alleviate discomfort.

Uses

You can use this product for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. Additionally, it offers both cooling and warming sensations to help soothe discomfort.

Rest assured, there are no teratogenic effects (which means it does not 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 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.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide specific 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 ensure that you use this product safely. You should not use it if the seal is broken or missing, as this could indicate that the product is compromised.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this product. Always prioritize your safety and check the packaging before use.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only apply it externally and avoid contact with your eyes. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and return shortly after, stop using the product and consult a doctor. Additionally, do not apply it to wounds or damaged skin, and avoid tightly bandaging the area.

Keep this product out of reach of children. If there is an accidental overdose or ingestion, seek medical help or contact a poison control center immediately. Also, do not use the product if the seal is broken or missing.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or any wounds and damaged skin. If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor.

It's important not to bandage the area tightly after application. In the event of an accidental overdose or if you accidentally ingest the product, seek immediate help by calling your doctor or a poison control center. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an accidental overdose or have ingested too much of a medication, it’s important to act quickly. Call your doctor or a poison control center right away for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms or changes in your body’s normal functions. If you notice any concerning signs, don’t hesitate to seek immediate medical help. Your health and safety are the top priority, so getting prompt assistance is crucial.

Pregnancy Use

When considering the use of Lightning Pain Relief menthol cream during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of the cream on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including topical treatments like this cream. They can help you weigh the potential risks and benefits based on your specific situation.

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 the ingredients may pass into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help ensure the safety and well-being of both you and your baby.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and 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, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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 wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided text. Therefore, if you have kidney issues, it's important to consult your healthcare provider for personalized advice and recommendations regarding any medications you may be taking. They can provide guidance tailored to your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). It's important to keep it away from direct sunlight and heat, as these can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. 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 the primary use of this drug?

This drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How often can I apply this product?

Adults and children 2 years of age and older can 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 warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with the eyes, and do not apply to wounds or damaged skin.

What should I do if the condition worsens?

If your condition worsens or symptoms persist for more than 7 days, discontinue use and consult a doctor.

Is this product safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, so consult a doctor before use.

Can nursing mothers use this product?

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

What should I do if the seal is broken or missing?

Do not use this product if the seal is broken or missing.

How should I store this product?

Store at room temperature between 15°-30° C (59°-86°F) and keep away from direct sunlight or heat.

Packaging Info

Below are the non-prescription pack sizes of Lightning Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lightning Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. It provides both cooling and warming pain relief.

Limitations of Use: 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.

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

Contraindications

Use of this product is contraindicated if the seal is broken or missing. This precaution is necessary to ensure the integrity and safety of the product.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

This product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, it is advised not to bandage the area tightly after application, as this may interfere with the product's efficacy and safety.

In cases of accidental overdose or ingestion, immediate medical attention is required. Healthcare professionals should instruct patients to contact a doctor or poison control center without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. In the event that the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a doctor. It is also important to avoid applying the product to wounds or damaged skin and to refrain from bandaging the area tightly.

Additionally, this product should be kept out of reach of children. In cases of accidental overdose or ingestion, it is crucial to contact a doctor or poison control center immediately. Patients should not use the product if the seal is broken or missing, as this may indicate compromised safety or efficacy.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 Lightning Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lightning Pain Relief.
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, it is advised to consult a doctor prior to use.

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 currently no information available regarding the use of Lightning Pain Relief menthol cream during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when recommending this product to pregnant patients.

Lactation

Lactating 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 known.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an accidental overdose or ingestion, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to contact a physician or a poison control center without delay.

Prompt intervention is crucial in managing potential overdosage situations. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of the overdose situation.

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 have been provided for LIGHTNING PAIN RELIEF - menthol cream.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical attention in the event of an accidental overdose or ingestion of the medication. Patients should be instructed to contact their doctor or a poison control center without delay to ensure appropriate management and care. It is essential for patients to understand the importance of prompt action in such situations to mitigate potential risks associated with overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, within the range of 15° to 30° C (59° to 86° F). Care should be taken to keep the product away from direct sunlight and heat to maintain its integrity and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Lightning Pain Relief, 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 Lightning Pain Relief, 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.