Game on Xtreme

Description

GAME ON Xtreme™ Warm Up Spray is presented in a net weight of 3.4 ounces (96 grams). This product is designed for use prior to physical activity, providing a warming effect to the targeted areas.

Uses and Indications

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

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

Dosage and Administration

The product should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is to spray the product on the affected area no more than 1 to 3 times daily. For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Application is contraindicated on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition. Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

Tight bandaging is contraindicated as it may restrict circulation. The use of heating pads in conjunction with this product is not recommended, as it may lead to increased absorption and potential adverse effects. Additionally, puncturing or incinerating the container is contraindicated due to the risk of explosion, as the contents are under pressure. Storage at temperatures exceeding 120°F is also contraindicated to maintain product integrity and safety.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must not be used while smoking or in proximity to heat or open flames. It is imperative to avoid application to wounds or any damaged, broken, or irritated skin. Additionally, contact with eyes or mucous membranes must be strictly avoided.

When utilizing this product, healthcare professionals should advise patients to keep it out of the eyes and to refrain from applying a tight bandage over the area of use. The use of heating pads in conjunction with this product is contraindicated. It should be used strictly as directed, and users must not puncture or incinerate the container, as it is under pressure. Storage should be maintained at temperatures not exceeding 120°F.

Patients should be instructed to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if the product is needed for longer than one week, medical advice should be sought.

In the event of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. It is crucial to avoid application to wounds or damaged, broken, or irritated skin, and to prevent contact with eyes or mucous membranes.

While using this product, patients should take care to keep it out of the eyes, avoid tight bandaging, and refrain from using it in conjunction with a heating pad. It is essential to use the product only as directed and to avoid puncturing or incinerating the container, as it is under pressure. Storage should be at temperatures not exceeding 120°F.

Patients are advised to discontinue use and consult a healthcare professional 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 the product is needed for longer than a week, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use. This product should be kept out of reach of children and pets; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Game on Xtreme (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is to apply the spray product to the affected area no more than 1 to 3 times daily.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and pets to prevent accidental ingestion or exposure. 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 apply the product to wounds or any damaged, broken, or irritated skin. It is important to emphasize that contact with the eyes or mucous membranes should be avoided. Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms clear up and then recur within a few days.

When using the product, patients should be reminded to keep it out of their eyes and to avoid bandaging tightly. They should not use the product in conjunction with a heating pad. It is crucial to instruct patients to use the product only as directed and to avoid puncturing or incinerating the container, as it is under pressure. Furthermore, patients should be cautioned against storing the product at temperatures exceeding 120°F.

Storage and Handling

The product is supplied in configurations that may vary, and it is important to handle it with care due to its potential to cause staining. Caution is advised when spraying near fabrics and unprotected surfaces to prevent any unwanted marks.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and extreme temperatures. It is recommended to store the product within a temperature range that ensures its stability and efficacy. Special handling precautions should be taken to avoid contact with sensitive materials and surfaces.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)