Instaflex Pain Relief Cream

Description

Instaflex is a pain-relieving cream formulated with an exclusive oxygenated oil, designed to provide fast relief for arthritis, joint, and muscle pain. The cream is clinically studied and developed by doctors, ensuring a reliable formulation. It offers powerful pain relief that begins within minutes and lasts for hours. The product is characterized by its deep penetrating, fast-acting properties, and is noted for its pleasant scent and non-greasy texture. Instaflex is available in net weights of 2 oz (57 g) and 4 oz (113 g).

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, 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 dosage is to apply the medication 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 professional prior to use.

The medication should be applied directly to the affected area, ensuring that the application does not exceed the specified frequency of 3 to 4 times daily for the appropriate age group.

Contraindications

Use of this product is contraindicated in the following situations:

The application of this product in conjunction with a heating pad is prohibited due to the potential risk of skin blistering. Additionally, it should not be applied to open wounds or damaged skin, as this may exacerbate injury or lead to further complications.

Warnings and Precautions

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

Healthcare professionals are advised to recommend that patients consult a physician prior to use if there is any redness present over the affected area.

When utilizing this product, it is imperative to follow the instructions provided. Users should avoid contact with the eyes and refrain from applying tight bandages over the treated area.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: development of skin redness or excessive irritation, worsening of the condition, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial resolution.

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

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is for external use only. Users should not apply it in conjunction with a heating pad, as this may lead to skin blistering. Additionally, the product should not be used on open wounds or damaged skin.

Before using this product, patients are advised to consult a doctor 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 tightly bandaging the area.

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

As a precaution, 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

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. It is advisable for healthcare professionals to remain vigilant and consult updated resources for any emerging data regarding potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Instaflex Pain Relief Cream (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

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of Instaflex Pain Relief Cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals are advised to exercise caution when recommending this product to pregnant patients. Due to the lack of available safety data, the potential risks to fetal outcomes remain unknown. It is recommended that women of childbearing potential discuss their individual circumstances with their healthcare provider before using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Instaflex Pain Relief Cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 for SPL code 90375-7.

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 the product in conjunction with a heating pad, as this may cause skin blistering. Additionally, it is important to emphasize that the product should not be applied to 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. They 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. Patients should be informed that if symptoms improve and then recur within a few days, they should also stop use and consult a doctor.

When using the product, patients must be instructed to follow the directions carefully and avoid contact with the eyes. They should also be cautioned against tightly bandaging the area where the product is applied. Finally, healthcare providers should recommend that patients consult a doctor before use if there is any redness 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 and efficacy. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3-4 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 prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)