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Premieres Pain

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Active ingredient
Menthol 0.07 g/1 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
December 23, 2025
Active ingredient
Menthol 0.07 g/1 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 2010
Label revision date
December 23, 2025
Manufacturer
Premiere Enterprises
Registration number
M017
NDC root
32472-102

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Drug Overview

Pain Spray™ is a natural herbal formula that provides temporary relief from minor aches and pains in your muscles and joints. It contains menthol, which helps soothe discomfort associated with various conditions such as arthritis, backache, stiff joints, sore muscles, sprains, and muscle cramps.

This product is designed to help you feel more comfortable and active by targeting those everyday aches. With its easy-to-use spray format, Pain Spray™ aims to be a convenient solution for managing your pain.

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, backache, stiff joints, sore muscles, sprains, 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

To use this medication effectively, you should shake the bottle well before applying it to the affected area. You can apply it up to 3 to 4 times a day. For added relief, consider using it after a warm shower or bath, as this can help enhance its effects.

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 other complications. Additionally, do not bandage the area tightly after application, 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 be aware of some potential side effects and safety precautions. You should only use it externally and keep it away from flames, as it is flammable. Make sure to keep it out of reach of children; if swallowed, seek medical help immediately. Avoid contact with your eyes and do not apply it to open wounds or damaged skin.

If you experience excessive skin irritation or have a history of allergic reactions to salicylates (like aspirin), consult your doctor. Additionally, if your condition worsens, persists for more than 7 days, or clears up and then returns 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, and store it out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison center immediately.

Be careful to avoid contact with your eyes, and do not apply the product 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 last more than 7 days, or if they improve and then come back within a few days, stop using the product and reach out to your doctor.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Seek medical help immediately or contact a poison center for guidance. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication.

Remember, timely action is crucial. Don’t wait for symptoms to worsen; getting professional help right away can make a significant difference in the outcome. Always keep emergency contact numbers handy and be aware of the nearest medical facilities.

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, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Because there are no specific studies on how this product impacts breastfeeding, it's best to exercise caution and discuss any concerns with your healthcare provider. Your health and the well-being of your baby are the top priorities.

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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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.

There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Pain Spray™ used for?

Pain Spray™ is used for the temporary relief of minor aches and pains of muscles and joints, including conditions like arthritis, backache, stiff joints, sore muscles, sprains, and muscle cramps.

How should I use 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. For extra relief, use it after a warm shower or bath.

Are there any warnings I should be aware of?

Yes, Pain Spray™ is for external use only and is flammable, so keep it away from flames. Avoid contact with eyes and do not apply to open wounds or damaged skin.

What should I do if I experience excessive skin irritation?

If you experience excessive skin irritation or are prone to allergic reactions to salicylates, including aspirin, consult a doctor. Discontinue use if the condition worsens or persists for more than 7 days.

Can I use Pain Spray™ if I am pregnant or breastfeeding?

There is no specific information regarding use during pregnancy. Nursing mothers should consult a doctor before using this product due to the potential for excretion in breast milk.

What should I do if Pain Spray™ is swallowed?

Keep Pain Spray™ out of reach of children. If swallowed, get medical help or contact a poison center right away.

Is there any specific storage instruction for Pain Spray™?

Yes, store 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 muscles and joints. Specifically, it provides relief for conditions such as arthritis, backache, stiff joints, sore muscles, sprains, and muscle cramps.

There are no 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 or causing infection. Additionally, do not apply tightly bandaged dressings, 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 doctor 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 should be aware that the product is for external use only and is flammable; it should be kept away from flames. In the event of accidental ingestion, it is crucial to keep the product out of reach of children and seek medical assistance or contact a poison center immediately.

Participants are advised to avoid contact with the eyes and not to apply the product to open wounds or damaged skin. It is also recommended not to bandage the area tightly after application.

In clinical use, if excessive skin irritation occurs, or if patients have a history of allergic reactions to salicylates, including aspirin, they should consult a doctor. Should the condition worsen, or if symptoms persist for more than 7 days or clear up and recur within a few days, discontinuation of the product and consultation with a healthcare professional is advised.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 product 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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding due to the lack of specific studies on its effects on nursing infants.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 use of the compound in question.

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. In the event of accidental ingestion, patients should seek medical assistance or contact a poison center immediately.

Patients should be instructed to avoid contact with the eyes and to refrain from applying the product to open wounds or damaged skin. It is important to inform patients not to bandage the area tightly after application.

Healthcare providers should counsel patients to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, patients should be informed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

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; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

For adults and children aged 2 years and older, the product should be shaken well before application to the affected area, with a recommended frequency of 3 to 4 times daily. Patients may experience enhanced relief by using the product following a warm shower or bath. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.