No Pain More Gain

Description

NPMG Ice Spray is a topical formulation designed for localized application. It is characterized by its unique composition, which includes NPMG as the active ingredient. The product is presented in an aerosol dosage form, facilitating ease of use and targeted delivery. The spray is designed to provide a cooling effect upon application, making it suitable for various therapeutic indications. The formulation is intended for external use only and should be applied as directed.

Uses and Indications

This drug is indicated for the management of local inflammatory and noninflammatory pain. It provides temporary yet long-lasting pain relief while also moisturizing the skin. The formulation features an innovative crackling spray that contains tiny bubbles, which burst upon contact with the skin to release unique pain-relieving properties.

NPMG Ice Spray is designed to deliver a cold sensation initially, followed by a warming effect. It can be applied selectively to targeted areas or over larger surfaces as needed. The product penetrates deeply and absorbs quickly, leaving a fresh and pleasant scent.

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. The product should be sprayed onto the affected area, ensuring even coverage. After application, patients should wait for 60 seconds until the crackling effect fades. Following this, the area should be gently massaged to enhance absorption.

The product may be applied 4 to 6 times a day, depending on the severity of the condition. It is important to emphasize that this product is not recommended for use in children under 12 years of age. Additionally, patients should wash their hands thoroughly after application to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, skin irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. The product should not be applied to irritated skin, as this may exacerbate the condition. Additionally, the treated area must not be wrapped, bandaged, or subjected to heat from a heating pad, as these actions could lead to adverse effects. The product is contraindicated for use on open wounds or broken skin.

Patients should be advised to discontinue use and contact their healthcare provider if any of the following occur: worsening of the condition, development of skin irritation, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical consultation is also recommended.

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 should not come into contact with the eyes or mucous membranes. It is contraindicated for use on irritated skin, open wounds, or broken skin. Additionally, patients should avoid wrapping, bandaging, or applying a heating pad to the treated area.

In the event that the condition worsens, skin irritation occurs, or symptoms persist for more than 7 days, or clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. These precautions are essential to ensure the safe and effective use of the 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 No Pain More Gain (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is important to keep the product out of reach of children to prevent accidental ingestion or misuse.

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 should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult a doctor if any of the following occur: the condition worsens, skin irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. It is important for patients to be aware of these signs and to seek medical advice promptly to ensure their safety and the effectiveness of their treatment.

Storage and Handling

The product is supplied in a pressurized container, which requires careful handling to ensure safety. It is essential to store the product in a cool, dry place, away from direct sunlight and any sources of heat. The recommended storage temperature should not exceed 120°F.

Users must avoid exposing the container to flames or hot surfaces, as this could lead to dangerous situations. Additionally, it is crucial to keep the product away from sources of ignition to prevent any risk of fire. The container should never be punctured or incinerated, as this could result in hazardous conditions.

When utilizing the product, it is advised to maintain a safe distance from the face and mouth to prevent inhalation of the contents. Proper adherence to these storage and handling guidelines will ensure the safe use of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for No Pain More Gain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)