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Hav Ez Penetrating Pain Relief

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Active ingredient
Menthol 30 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
February 1, 2024
Active ingredient
Menthol 30 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
February 1, 2024
Manufacturer
PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC
Registration number
M017
NDC root
84093-442

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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 associated with arthritis, simple backaches, strains, bruises, and sprains. This means that if you're dealing with discomfort from these issues, this medication could provide you with some much-needed relief.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for discomfort associated with conditions like arthritis, simple backache, strains, bruises, and sprains. If you're dealing with any of these issues, this medication may help ease your pain and improve your comfort.

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. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to be cautious when using this medication. You should avoid applying it to any damaged or broken skin, as this could lead to complications or reduce its effectiveness.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow your healthcare provider's instructions for safe use.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if you develop a rash or irritation that lasts, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement. Additionally, avoid using the product on damaged or broken skin, and keep it away from your eyes.

If swallowed, seek medical help immediately or contact a Poison Control Center. If you are pregnant or breastfeeding, it's advisable to consult a healthcare professional before using this product. Always keep it out of reach of children.

Warnings and Precautions

This product is for external use only, so please avoid applying it to damaged or broken skin. While using it, be careful not to get it in your eyes, and do not wrap the area tightly with a bandage.

If you notice a rash or irritation that lasts, or if your condition worsens or does not improve after 7 days, stop using the product and consult your doctor. Keep this product out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product.

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 symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. 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 receive personalized advice that considers your health and the well-being of your baby. Always prioritize open communication with your doctor to make informed decisions about your care during this time.

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 it 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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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 should be used 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 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 safety and effectiveness of your product, it's important to store it properly. Keep the product in its container and protect it from excessive heat and direct sunlight. This will help maintain its quality and functionality.

When handling the product, always do so with care to avoid any damage. Following these simple guidelines will help you use the product safely and effectively.

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 postmarketing experiences related to this medication.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of minor aches and pains of muscles and joints, associated with conditions like arthritis, simple backache, strains, bruises, and sprains.

How should I apply this drug?

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 this drug?

You should not use this drug on damaged or broken skin.

What should I do if I experience a rash or irritation?

Stop using the product and ask a doctor if a rash or irritation develops and lasts, or if your condition worsens or persists for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What precautions should I take while using this drug?

Avoid contact with the eyes and do not bandage the area tightly while using this product.

What should I do if the drug is swallowed?

Keep this drug out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Packaging Info

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

Packaging configurations for Hav Ez Penetrating Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, 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 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 is contraindicated on damaged or broken skin due to the potential for adverse effects and compromised healing. No other contraindications have been specified.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to damaged or broken skin to prevent adverse reactions.

When utilizing this product, care should be taken to avoid contact with the eyes. Additionally, it is advised not to apply tight bandages over the treated area, as this may lead to complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a rash or irritation develops and persists, if the condition worsens, or if symptoms do not improve after 7 days. Patients should also be advised to consult a healthcare provider if symptoms resolve and then recur within a few days.

To ensure safety, 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 is recommended.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to assess any potential risks.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to damaged or broken skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

In the event that a rash or irritation develops and persists, or if the condition worsens, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or if they resolve and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to using this product to ensure safety.

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 Hav Ez Penetrating Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hav Ez Penetrating 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

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 healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on damaged or broken skin. They should be informed to stop using the product and consult a doctor if a rash or irritation develops and persists, if the condition worsens, or if symptoms last longer than 7 days or reoccur within a few days after improvement.

While using this product, patients should be cautioned to avoid contact with the eyes and to refrain from applying a tight bandage over the treated area.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, clinicians are advised to consult a doctor 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 Hav Ez Penetrating 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 Hav Ez Penetrating 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.

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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.