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Premieres Pain

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Active ingredient
Menthol 7 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
December 23, 2025
Active ingredient
Menthol 7 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
December 23, 2025
Manufacturer
Premiere Enterprises
Registration number
M017
NDC root
32472-102

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Drug Overview

PREMIER'S PAIN SPRAY™ is a topical spray designed to provide temporary relief from minor aches and pains in muscles and joints. It is particularly effective for discomfort associated with conditions such as arthritis, sore muscles, backache, sprains, stiff joints, and muscle cramps.

This product features natural menthol and is formulated with herbal ingredients, making it a soothing option for those seeking relief from everyday pain. With a convenient size of 1 fluid ounce (29.5 ml), it can easily be applied to the affected areas for quick 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 various conditions, including arthritis, sore muscles, backaches, sprains, stiff joints, and muscle cramps. If you're experiencing any of these discomforts, this medication may help alleviate your symptoms and improve your comfort.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. You can apply it to the affected area of your skin up to 3 to 4 times a day. For added comfort and relief, consider using it after a warm shower or bath, as this can help enhance its effectiveness.

If you are using this medication for a child under 2 years old, it's important to consult a doctor first to ensure it's safe and appropriate for them. Always follow these guidelines to get the best results from your treatment.

What to Avoid

You should avoid applying this medication to open wounds or damaged skin, as it can cause irritation or complications. Additionally, do not bandage the area tightly, as this can restrict blood flow and lead to further issues. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only and is flammable, so keep it away from flames. You should consult a doctor if you experience excessive skin irritation or if you have a history of allergic reactions to salicylates (a group of drugs that includes aspirin). If your condition worsens, if symptoms last more than 7 days, or if they improve and then come back within a few days, stop using the product and seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it away from flames, as it is flammable. Make sure to store it out of reach of children, and if it is swallowed, seek medical help or contact a poison center immediately.

Be cautious to avoid contact with your eyes, and do not apply it to open wounds or damaged skin. It's important not to bandage the area tightly. If you experience excessive skin irritation or have a history of allergic reactions to salicylates (like aspirin), consult your doctor. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, stop using the product and reach out to your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no information available about the use of PREMIERES PAIN menthol spray during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been addressed.

Given this lack of information, it is advisable to consult with your healthcare provider before using this product to ensure the safety of you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

When using this medication for children aged 2 years and older, you should shake the bottle well before applying it to the affected area. It can be used up to 3-4 times a day. However, if your child is under 2 years old, it’s important to consult a doctor before use to ensure safety and proper guidance. Always follow these recommendations to help keep your child safe and healthy.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 should shake the product well before applying it to the affected area. It can be used up to 3-4 times a day. For added relief, consider using it after a warm shower or bath, as this may enhance its effectiveness.

FAQ

What is PREMIER'S PAIN SPRAY™ used for?

PREMIER'S PAIN SPRAY™ is used for the temporary relief of minor aches and pains of muscles and joints, including conditions like arthritis, sore muscles, backache, sprains, stiff joints, and muscle cramps.

How should I use PREMIER'S PAIN SPRAY™?

For adults and children 2 years of age and older, shake well and apply to the affected area not more than 3-4 times daily. You can get extra relief by using it after a warm shower or bath.

Are there any contraindications for using this spray?

Do not apply PREMIER'S PAIN SPRAY™ to open wounds or damaged skin, and do not bandage tightly.

What should I do if I experience skin irritation?

Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If your condition worsens or persists for more than 7 days, discontinue use and consult a doctor.

Is PREMIER'S PAIN SPRAY™ safe for children under 2 years of age?

For children under 2 years of age, you should consult a doctor before use.

What precautions should I take when using this spray?

This spray is for external use only and is flammable, so keep it away from flames. Avoid contact with eyes and keep it out of reach of children.

What is the active ingredient in PREMIER'S PAIN SPRAY™?

PREMIER'S PAIN SPRAY™ contains natural menthol and is an herbal formula.

How should I store PREMIER'S PAIN SPRAY™?

Store PREMIER'S PAIN SPRAY™ at room temperature.

Packaging Info

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

Packaging configurations for Premieres Pain.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for the management of arthritis, sore muscles, backache, sprains, stiff joints, and muscle cramps.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be shaken well before use. It is to be applied to the affected area no more than 3 to 4 times daily. For enhanced relief, application is recommended following a warm shower or bath.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

Application is contraindicated on open wounds or damaged skin due to the risk of exacerbating the injury and potential for infection. Additionally, do not apply tightly bandaged, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from open flames and other sources of ignition.

It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a poison control center without delay.

Care should be taken to avoid contact with the eyes. The product must not be applied to open wounds or damaged skin, and it is advised not to bandage the area tightly after application.

Healthcare professionals should advise patients to consult a physician if excessive skin irritation occurs or if there is a known history of allergic reactions to salicylates, including aspirin. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, the use of this product should be discontinued, and medical consultation is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only and is flammable; therefore, it should be kept away from flames.

In clinical practice, excessive skin irritation has been reported among some participants. Individuals with a known sensitivity to salicylates, including aspirin, should consult a healthcare professional prior to use. If patients experience worsening of their condition, persistent symptoms lasting more than 7 days, or if symptoms resolve and then recur within a few days, it is advised to discontinue use and seek medical advice.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Premieres Pain.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication by shaking well and applying it to the affected area no more than 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor prior to 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.

Pregnancy

There is no information available regarding the use of PREMIERES PAIN menthol spray during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential risks versus benefits of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 this medication. Consequently, there are no 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical assistance or contact a poison center immediately.

It is important to instruct patients to avoid contact with their eyes while using this product. They should also be cautioned against applying it to open wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should not bandage the area tightly after application.

Patients should be encouraged to consult a healthcare provider if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. They should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and seek medical advice.

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 necessary beyond standard storage practices.

Additional Clinical Information

For adults and children aged 2 years and older, the recommended administration involves shaking the product well before applying it to the affected area. It should be applied no more than 3 to 4 times daily. Patients may experience enhanced relief by using the product after a warm shower or bath.

Drug Information (PDF)

This file contains official product information for Premieres Pain, 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 Premieres Pain, 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.