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Gerigentle Frostyheat Pain Relief Patch Arm and Neck

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Active ingredient
Menthol 50 mg/1 mL
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
November 10, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 50 mg/1 mL
Other brand names
Dosage form
Patch
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 2022
Label revision date
November 10, 2023
Manufacturer
Geri-Gentle Corporation
Registration number
M017
NDC root
69771-011
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

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for various conditions, including arthritis, simple backache, strains, sprains, and bruises. If you're experiencing discomfort from any of these issues, this drug may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for discomfort caused by conditions such as arthritis, simple backaches, strains, sprains, and bruises.

This means that if you're dealing with any of these issues, this medication can help ease your pain and improve your comfort. Always remember to follow the recommended guidelines for use.

Dosage and Administration

To use this medication, start by cleaning and drying the area of your skin that is affected. If you are an adult or a child aged 12 years and older, you can proceed with the next steps. For children under 12, it's important to consult a physician before use.

Once the area is prepared, remove the film from the patch and apply it directly to the clean, dry skin. You should only use one patch at a time and can apply it to the affected area up to three to four times a day. Remember, each patch should not be worn for more than 8 hours at a time. Following these guidelines will help ensure you use the medication safely and effectively.

What to Avoid

You should avoid using this product on any wounds or damaged skin, as it may cause irritation or worsen your condition. Additionally, do not use it in conjunction with a heating pad, as this could lead to unwanted effects. If you have a known allergy to any ingredient in this product, it is important not to use it, as this could trigger an allergic reaction. Always prioritize your safety and well-being by following these guidelines.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if you experience excessive redness or irritation, or if symptoms persist for more than seven days. Additionally, if your symptoms improve and then return within a few days, seek medical advice.

This product is for external use only and should not be applied to wounds or damaged skin. Avoid using it with a heating pad, and be cautious to keep it away from your eyes and mucous membranes. If you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep the product out of reach of children and pets, and seek immediate medical help if it is swallowed.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Do not use it with a heating pad, and make sure you are not allergic to any of its ingredients before use. When applying, follow the directions carefully and steer clear of your eyes, mucous membranes, and any rashes.

If you notice that your condition worsens, experience excessive redness or irritation, or if your symptoms last longer than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then return within a few days, it's important to seek medical advice. Always keep this product out of reach of children and pets, and if it is swallowed, get 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. Acting quickly can make a significant difference in the outcome.

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, it’s always better to be safe and seek assistance if you suspect an overdose.

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 professional 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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, you should clean and dry the affected area before applying the treatment. However, if your child is under 12 years old, it's essential to consult a physician (a medical doctor) before using the medication to ensure it's 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 wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to drugs.

Always ensure that your doctor is aware of any other medications being taken, as well as any existing health conditions. This will help in determining the safest and most effective treatment plan tailored to your needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using certain medications or treatments. For instance, you should avoid using a heating pad while taking this medication, as it can lead to unwanted effects. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.

Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to inform your healthcare provider about all medications you are using. This way, they can provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place away from direct sunlight. This helps maintain its effectiveness and prevents any damage. Additionally, it's important to protect the product from excessive moisture, as this can compromise its quality and safety.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the patch to the affected area, using one patch at a time, and not more than 3 to 4 times a day. Each patch can be worn for a maximum of 8 hours. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep the patches out of reach of children and pets. If a patch is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, and bruises.

How should I apply the patch?

Clean and dry the affected area, then remove the film from the patch and apply it to the skin. You can apply 1 patch at a time, not more than 3 to 4 times daily, and wear each patch for a maximum of 8 hours.

Are there any contraindications for using this drug?

Do not use this drug on wounds or damaged skin, with a heating pad, or if you are allergic to any ingredient in the product.

What should I do if I experience excessive redness or irritation?

Stop using the product and ask a doctor if conditions worsen, excessive redness or irritation occurs, or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if the patch is swallowed?

Keep the product out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.

What precautions should I take when using this product?

Use only as directed, avoid contact with eyes and mucous membranes, and do not use on wounds or damaged skin.

Packaging Info

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

Packaging configurations for Gerigentle Frostyheat Pain Relief Patch Arm and Neck.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints due to conditions such as arthritis, simple backache, strains, sprains, and bruises.

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

Dosage and Administration

Adults and children 12 years of age and older should clean and dry the affected area prior to application. For individuals under 12 years of age, consultation with a physician is recommended before use.

To apply the patch, remove the film from the patch and place it on the clean, dry skin over the affected area. A maximum of one patch should be applied at a time, with a frequency of no more than 3 to 4 applications per day. Each patch may be worn for a maximum duration of 8 hours.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application on wounds or damaged skin is prohibited due to the potential for adverse effects and impaired healing.

  • Concurrent use with a heating pad is not recommended, as it may lead to increased risk of burns or skin irritation.

  • Individuals with a known allergy to any ingredient in this product should avoid its use to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Individuals with known allergies to any ingredient in this formulation should refrain from use.

When utilizing this product, it is imperative to adhere strictly to the provided directions. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes, as this may lead to adverse effects.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of conditions, excessive redness or irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. It is contraindicated for use with heating pads and in individuals who are allergic to any ingredient in the formulation.

During the use of this product, it is essential to follow the directions provided. Patients should avoid contact with the eyes, mucous membranes, and any rashes. If conditions worsen, excessive redness or irritation occurs, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. This product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

The use of this medication is contraindicated with heating pads due to the potential for increased risk of adverse effects. It is advised that patients refrain from using heating pads while on this medication to avoid any complications.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not required for interactions with laboratory tests.

Packaging & NDC

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

Packaging configurations for Gerigentle Frostyheat Pain Relief Patch Arm and Neck.
Details

Pediatric Use

Pediatric patients aged 12 years and older should clean and dry the affected area prior to application. For children under 12 years of age, it is advised to consult a physician 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 healthcare 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 mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion or misuse. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad, as this may lead to adverse effects. It is essential to discuss the importance of not using the product if they have a known allergy to any of its ingredients.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens, if they experience excessive redness or irritation, or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if their symptoms clear up and then recur within a few days.

When using this product, patients must be reminded to follow the directions carefully and to avoid contact with the eyes, mucous membranes, or any rashes to prevent irritation or complications.

Storage and Handling

The product is supplied in configurations that are compliant with the National Drug Code (NDC) standards. It is essential to store the product in a cool, dry place, away from direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application of one patch at a time to the affected area, not exceeding three to four applications daily. Each patch should be worn for a maximum of eight hours.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children and pets. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Gerigentle Frostyheat Pain Relief Patch Arm and Neck, 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 Gerigentle Frostyheat Pain Relief Patch Arm and Neck, 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.

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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.