Instaflex Pain Relief Roll-on

Description

Instaflex is a topical formulation designed for pain relief, specifically targeting arthritis, joint, and muscle discomfort. It is composed of an exclusive oxygenated oil that facilitates deep penetration into the affected areas. The product is characterized by its fast-acting properties and is presented in a convenient roll-on applicator, ensuring ease of use without the mess typically associated with topical treatments. Instaflex is non-greasy and emits a pleasant aroma, enhancing the user experience. Each container has a net weight of 2.5 oz (71 g).

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 arthritis, strains, sprains, and bruises.

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

Dosage and Administration

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. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with a heating pad due to the risk of skin blistering. Additionally, the product should not be applied to open wounds or damaged skin, as this may exacerbate injury or lead to adverse effects.

Warnings and Precautions

For external use only. This product should not be applied in conjunction with a heating pad, as this may lead to skin blistering. It is contraindicated for use on open wounds or damaged skin.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: skin redness or excessive irritation develops; the condition worsens or symptoms persist beyond 7 days; or if symptoms resolve and then reappear within a few days.

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 with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be applied in conjunction with a heating pad, as this may lead to skin blistering. It is contraindicated for use on open wounds or damaged skin.

Before using this product, patients are advised to consult a healthcare professional if there is any redness over the affected area. While using the product, it is crucial to adhere strictly to the directions provided, avoid contact with the eyes, and refrain from applying tight bandages.

Patients should discontinue use and seek medical advice if they experience skin redness or excessive skin irritation. Additionally, if the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days, medical consultation is recommended.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

The use of this medication in conjunction with a heating pad is contraindicated, as it may lead to skin blistering. Caution should be exercised to avoid this combination to prevent adverse skin reactions.

No specific drug or laboratory test interactions have been identified. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Instaflex Pain Relief Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3-4 times daily.

Geriatric Use

Elderly patients may use Instaflex Pain Relief Roll-On without specific warnings, dosage adjustments, or special precautions as indicated in the prescribing information. However, healthcare providers should remain vigilant in monitoring for any potential adverse effects, as individual responses to treatment may vary in this population. It is advisable to assess the overall health status and concurrent medications of geriatric patients to ensure safe and effective use of the product.

Pregnancy

There is currently no information available regarding the use of Instaflex Pain Relief Roll-On during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals are advised to exercise caution and consider the absence of data when discussing the use of this product with women of childbearing potential.

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 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 drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 provided 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 Control Center immediately.

Patients should be informed not to use this product in conjunction with a heating pad, as this may cause skin blistering. Additionally, it is important to instruct patients to avoid applying the product on open wounds or damaged skin.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience skin redness or excessive irritation. Patients should also be advised to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than seven days. Furthermore, if symptoms resolve and then reoccur within a few days, patients should be instructed to stop use and consult a healthcare professional.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and refrain from tightly bandaging the area where the product is applied. Lastly, patients should be encouraged to consult a doctor prior to use if there is any redness present over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a temperature range of 59-86°F (15-30°C) and a relative humidity of 40%. Freezing the product is strictly prohibited, as it may compromise its integrity. Proper handling and storage conditions are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

For patients aged 12 years and older, the medication should be applied to the affected area no more than 3-4 times daily. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use and administration of the product. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)