Pain Crush

Description

Genexa® COLD THERAPY PAIN RELIEF ROLL ON, branded as PAIN CRUSH™, is a topical analgesic formulation containing menthol. This product is designed for the relief of back pain, arthritis, sore muscles, joints, and pain in the shoulder and legs. It is presented in a dosage form of 3 fluid ounces (89 mL). The formulation is USDA Organic and Non-GMO Project Verified, ensuring it is free of dyes and parabens. The National Drug Code (NDC) for this product is 69676-0004-6.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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 each use. For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. For children under 12 years of age, it is essential to consult a physician prior to use.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for adverse effects and impaired healing. Additionally, the product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

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

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Additionally, if excessive skin irritation develops, patients should stop using the product and seek medical advice.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately to ensure appropriate management and care.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, it is advised that patients stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if excessive skin irritation occurs, patients should seek medical advice.

Before using the product, patients are encouraged to consult a doctor if there is any redness over the affected area.

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 Pain Crush (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients should not use this medication in children under 12 years of age with arthritis-like conditions. For adults and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a healthcare provider before use. Caution is warranted when prescribing this medication to geriatric patients, and careful consideration of the patient's overall health status and potential for adverse effects is recommended. Monitoring for efficacy and safety is essential, particularly in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is crucial to document the incident thoroughly and report any adverse effects to the relevant regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of preventive measures, including patient education on the correct use of the medication and the importance of adhering to prescribed dosages.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product on wounds or damaged skin, and it is contraindicated for use in children under 12 years of age with arthritis-like conditions. Providers should emphasize the importance of discontinuing use and consulting a doctor if the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, patients should be cautioned to stop use and seek medical advice if excessive skin irritation occurs. It is important to instruct patients to avoid contact with eyes or mucous membranes while using this product. They should also be advised against tightly bandaging the area or using a heating pad in conjunction with the product.

Finally, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in a container that requires careful handling to maintain its integrity. It should be stored at a temperature range of 20 to 25°C (68 to 77°F). After each use, it is essential to close the cap tightly to prevent contamination and ensure the product's efficacy. For reference, the Lot Number and Expiration Date can be found at the bottom of the bottle.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)