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Ralli Rapid Pain Relief

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Active ingredient
Menthol 100 mg/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 2024
Label revision date
July 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 100 mg/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 2024
Label revision date
July 12, 2024
Manufacturer
Troy Manufacturing, Inc.
Registration number
M017
NDC root
63936-9753
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 can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means that if you're experiencing discomfort from these issues, this drug may provide you with some relief.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on it to ease discomfort from these common issues, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage these minor ailments.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication directly to the affected area of your skin. There’s no need to cover it with a bandage. You can repeat the application if necessary, but make sure not to apply it more than 3 to 4 times in a single day.

For children under 2 years of age, it’s important not to use this medication without first consulting a doctor. Always ensure you follow these guidelines to use the medication safely and effectively.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid bandaging tightly or using a heating pad while using this product, as these actions can lead to complications. Additionally, do not apply the medication to wounds or damaged skin, as this can cause irritation or other issues.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about your treatment, please consult your healthcare provider for personalized advice.

Side Effects

You should be aware that this product is for external use only, and you should avoid contact with your eyes. It is also flammable, so keep it away from fire or flames.

If your condition worsens, if symptoms last more than 7 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 notice any redness or excessive irritation of the skin, it's important to seek medical advice.

Warnings and Precautions

You should use this product only on the skin and avoid contact with your eyes. Remember that it is flammable, so keep it away from fire or flames. Always follow the directions provided and do not wrap the area tightly or use a heating pad. It's important not to apply it to wounds or damaged skin.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and call your doctor. You should also reach out to your doctor if you notice any redness or if your skin becomes excessively irritated.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

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 not to use this product without first consulting a doctor. For children aged 2 years and older, you can apply the product directly to the affected area. There’s no need to cover it with a bandage, and you can repeat the application if necessary. However, make sure not to apply it more than 3 to 4 times a day to ensure their safety. Always follow these guidelines to help keep your child safe and healthy.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have kidney issues, it's important to consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help ensure your treatment is safe and effective based on your individual health needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

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

Additional Information

For adults and children aged 2 years and older, you can apply the medication directly to the affected area without needing to cover it with a bandage. You may repeat the application if necessary, but do not apply it more than 3 to 4 times a day. If your child is under 2 years old, it's important to consult a doctor before use.

FAQ

What is the drug used for?

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

How should I apply the drug?

For adults and children 2 years of age and older, apply directly onto the affected area without the need to bandage. You can repeat the application if necessary, but do not apply more than 3 to 4 times daily.

Can I use this drug on children under 2 years of age?

No, do not use this drug on children under 2 years of age without consulting a doctor.

What precautions should I take when using this drug?

Use only as directed, do not bandage tightly or use a heating pad, and avoid applying it to wounds or damaged skin.

What should I do if my condition worsens?

Stop use and call your doctor if your condition worsens, if symptoms persist for more than 7 days, or if redness or excessive irritation of the skin develops.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do in case of accidental ingestion?

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

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

What are the storage instructions for this drug?

Store the drug at room temperature.

What are the warnings associated with this drug?

This drug is for external use only, avoid contact with eyes, and it is flammable, so keep it away from fire or flame.

Packaging Info

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

Packaging configurations for Ralli Rapid Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Ralli Rapid 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 SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the other. 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied directly to the affected area. There is no requirement for bandaging after application. The application may be repeated as necessary; however, it is important not to exceed 3 to 4 applications within a 24-hour period.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of heating pads is not recommended, as these practices may exacerbate adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent potential complications and ensure safety.

Warnings and Precautions

For external use only; direct contact with the eyes must be avoided to prevent irritation. The product is flammable; therefore, it should be kept away from fire or flame to mitigate the risk of combustion.

It is imperative to use this product only as directed. Users should refrain from bandaging the area tightly or applying a heating pad, as these actions may exacerbate potential adverse effects. Additionally, the product should not be applied to wounds or damaged skin to ensure safety and efficacy.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The presence of redness or excessive skin irritation also warrants immediate consultation with a healthcare provider.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be avoided to prevent irritation. Additionally, the product is flammable; therefore, it should be kept away from fire or flame.

Patients are advised to discontinue use and consult a healthcare professional 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. The presence of redness or excessive skin irritation also warrants immediate medical consultation. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Ralli Rapid Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ralli Rapid Pain Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication and must consult a doctor for guidance. For adults and children aged 2 years and older, the medication should be applied directly to the affected area without the need for bandaging. Applications may be repeated as necessary, but should not exceed 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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

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

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data necessitates careful evaluation of potential risks and benefits.

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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound 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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed 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, they should seek medical advice if they notice any redness or experience excessive irritation of the skin.

When using this product, patients must be reminded to use it only as directed. They should avoid bandaging the area tightly or using a heating pad in conjunction with the product. Furthermore, patients should not apply the product to wounds or damaged skin to ensure safe and effective use.

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 to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied directly to the affected area without the need for a bandage. It may be reapplied as necessary, but should not exceed 3 to 4 applications per day. For children under 2 years of age, the product is not recommended, and consultation with a doctor is advised.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ralli Rapid 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 Ralli Rapid 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.