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Instaflex Extra Strength Pain Relief Cream

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This product has been discontinued

Active ingredients
  • Menthol 25 mg/1 g
  • Methyl Salicylate 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
January 11, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 25 mg/1 g
  • Methyl Salicylate 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
January 11, 2019
Manufacturer
Healthy Directions, LLC
Registration number
part348
NDC root
70015-660
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Instaflex is an extra strength pain-relieving cream designed to provide temporary relief from minor aches and pains in muscles and joints. It is particularly effective for conditions such as arthritis, simple backache, strains, sprains, and bruises. Formulated with an exclusive oxygenated oil and double the pain-fighting ingredients, Instaflex features enhanced menthol power for deep penetration and fast-acting relief, making it a great option for nighttime use.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backache, arthritis, strains, sprains, and bruises. If you're dealing with any of these issues, this medication may help ease your discomfort and improve your mobility.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 12 years or older. This helps ensure that you get the best results while minimizing the risk of side effects.

If you have a child under 12 years of age, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use and dosage for younger patients. Always follow your healthcare provider's instructions for safe and effective use.

What to Avoid

It's important to be cautious when using this medication. You should never use it with a heating pad, as this can cause skin blisters. Additionally, avoid applying it to open wounds or any damaged skin, as this can lead to further complications.

If you have any concerns about misuse or dependence (which refers to the body's reliance on a substance), please consult your healthcare provider for guidance. Always prioritize your safety and well-being when using any medication.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if you experience skin redness or excessive irritation, if your condition worsens, or if symptoms persist for more than 7 days. Additionally, if your symptoms improve and then return after a few days, seek medical advice.

Please remember that this product is for external use only. Avoid using it with a heating pad, as this may cause skin blisters, and do not apply it to open wounds or damaged skin. If you notice any redness in the area you're treating, consult a doctor before continuing use. Always keep this product out of reach of children, and if swallowed, seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on open wounds or damaged skin, and do not apply it with a heating pad, as this may cause skin blisters. If you notice any redness in the area you are treating, it's important to consult your doctor before using the product.

When using this product, follow the instructions carefully. Make sure to keep it away from your eyes and avoid wrapping the area too tightly. If you experience skin redness or excessive irritation, or if your condition worsens or does not improve after 7 days, stop using the product and contact your doctor. Additionally, if your symptoms improve and then return a few days later, reach out to your healthcare provider.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to know that the safety of this product during pregnancy has not been established. You should consult your healthcare provider before using it, as there may be potential risks to your fetus that are not clearly defined.

There are no specific dosage modifications provided for pregnant individuals, so it’s best to seek personalized advice from your doctor regarding its use. Always prioritize your health and the health of your baby by discussing any medications or treatments with your healthcare professional.

Lactation Use

If you are breastfeeding, you can use Instaflex Extra Strength Pain Relief Cream without specific warnings or recommendations against it. Currently, there is no information available about whether this cream is passed into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns about using new products while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 12 years and older, you can apply the medication to the affected area up to 3-4 times a day. However, if your child is under 12 years old, you should consult a doctor before use to ensure it's safe and appropriate for them.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so please take these precautions seriously.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using certain products together. For instance, you should avoid using this medication with a heating pad, as it can cause skin blisters. Always discuss any medications or treatments you are considering with your healthcare provider to ensure your safety and well-being.

While there are no specific interactions with other drugs or laboratory tests noted, it's still essential to keep your healthcare provider informed about all the medications you are taking. This helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59-86°F (15-30°C), and maintain a humidity level of around 40%. It's important to avoid freezing the product, as this can affect its effectiveness and safety.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Instaflex?

Instaflex is an extra strength pain relieving cream designed to temporarily relieve minor aches and pains of muscles and joints.

What are the main uses of Instaflex?

Instaflex is used for relief from simple backache, arthritis, strains, sprains, and bruises.

How should I use Instaflex?

Apply Instaflex to the affected area no more than 3-4 times daily for adults and children 12 years and older. Consult a doctor for children under 12.

Are there any contraindications for using Instaflex?

Do not use Instaflex with a heating pad, on open wounds, or damaged skin, as it may cause blistering.

What should I do if I experience skin irritation while using Instaflex?

Stop using Instaflex and consult a doctor if you experience skin redness, excessive irritation, or if your condition worsens.

Is Instaflex safe to use during pregnancy?

The safety of Instaflex during pregnancy has not been established, so consult a healthcare provider before use.

Can I use Instaflex while nursing?

There are no specific warnings regarding the use of Instaflex in nursing mothers, but consult a doctor for personalized advice.

What should I do if Instaflex is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately.

What are the storage conditions for Instaflex?

Store Instaflex at room temperature and humidity, between 59-86°F (15-30°C), and do not freeze.

Packaging Info

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

Packaging configurations for Instaflex Extra Strength Pain Relief Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Instaflex is an extra strength pain-relieving cream formulated with an exclusive oxygenated oil. This topical preparation is designed to provide fast, extra strength relief for arthritis, joint, and muscle pain. It contains double the pain-fighting ingredients and double the menthol power, enhancing its efficacy. The cream is characterized by its deep penetrating and fast-acting properties, making it suitable for nighttime use. Developed by medical professionals, 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 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 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

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 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 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 use it strictly as directed. Care should be taken to avoid contact with the eyes, and patients should be instructed not to apply tight bandages over the treated area.

Patients must be informed 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.

Additionally, this product should be stored 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 7 days. Additionally, if symptoms resolve and then 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 is contraindicated with heating pads, as this combination may lead to skin blistering.

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

Packaging & NDC

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

Packaging configurations for Instaflex Extra Strength Pain Relief Cream.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication 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 prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised when considering the use of this product in this population. There are no specific dosage modifications for pregnant individuals provided; personalized advice from a healthcare professional is recommended to ensure safety and appropriateness of use.

Lactation

There are no specific warnings or recommendations regarding the use of Instaflex Extra Strength Pain Relief Cream in lactating 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 text 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 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 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 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 7 days. Patients should be informed that if symptoms resolve and then recur within a few days, they should also consult a doctor.

When using this 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 experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Instaflex Extra Strength Pain Relief Cream, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.