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 product is clinically studied and developed by medical professionals, ensuring its efficacy. It offers powerful pain relief that begins within minutes and lasts for hours. The cream is characterized by its deep penetrating, fast-acting properties, and is formulated to be pleasant smelling and non-greasy. 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.

Limitations of Use: There are no reported 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 clean and dry prior to application.

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 for use in the following situations:

• Application with a heating pad is not recommended due to the risk of skin blistering.

• The product should not be applied to open wounds or damaged skin to prevent further irritation or complications.

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. When administering this product, it is imperative to follow the instructions provided and to avoid contact with the eyes. Additionally, patients should be cautioned against applying tight bandages over the treated area.

Patients must 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, or persistence of symptoms beyond 7 days. If symptoms initially resolve and then recur within a few days, medical consultation is also recommended.

It is essential 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 should be made without delay.

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 the 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 irritation, if the condition worsens, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

As a precaution, the 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 as new data may emerge.

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 Instaflex Pain Relief Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or interactions. It is advisable to consider the overall health status and individual needs of geriatric patients when recommending this treatment.

Pregnancy

There is currently no information available regarding the use of Instaflex Pain Relief Cream 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 should exercise caution and consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients 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 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 7 days. If symptoms resolve and then recur 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 and to avoid contact with the eyes. They should also be cautioned against tightly bandaging the area where the product is applied. Finally, patients with redness over the affected area should be encouraged to consult a doctor before using the product.

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 to ensure its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to preserve the quality of the product.

Additional Clinical Information

For adults and children aged 12 years and older, the medication should be applied 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 doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)