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 by a healthcare professional.

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 an initial cooling sensation followed by warmth, making it suitable for selective application or for use on larger areas of the body. 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, it is recommended to gently massage the product into the skin.

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 intended for use in children under 12 years of age. Additionally, patients should wash their hands thoroughly after using the product to prevent unintentional contact with other areas of the body or with others.

Contraindications

There are no 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 can lead to increased absorption and potential 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. Regular monitoring of the skin condition is advised to ensure safety and efficacy during treatment.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The 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 stop use and consult a healthcare professional. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been noted. There are no dosage modifications required for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy are included in the prescribing information. Healthcare professionals should continue to monitor the health of both the mother and fetus as part of standard prenatal care.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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 in these patients to ensure their safety while on treatment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of drug overdosage.

Recommended Actions In the event of an overdosage, it is essential to assess the patient's clinical status promptly. Healthcare providers should initiate supportive care, which may include monitoring vital signs and providing symptomatic treatment as necessary.

Potential Symptoms While specific symptoms related to overdosage are not detailed, practitioners should remain vigilant for any unusual or severe reactions that may arise following excessive intake of the medication.

Management Procedures Management of overdosage should be tailored to the individual patient and may involve contacting a poison control center for guidance. In cases where the substance is known to have antidotes or specific treatment protocols, these should be implemented as appropriate.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to the understanding of the drug's safety profile.

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 compound in these areas.

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 product 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. Additionally, patients should be informed to seek medical advice if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in containers that are under pressure. It is essential to store the product in a cool, dry place, away from direct sunlight and any sources of ignition. The storage temperature must not exceed 120°F (49°C).

Users should avoid spraying the product near flames or hot surfaces, as this may pose a safety risk. Additionally, the container should not be punctured or incinerated, as this could lead to hazardous situations. When utilizing the product, it is advised to maintain a safe distance from the face and mouth to prevent inhalation.

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)