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Osteo Bi-Flex Joint Health Pain Relieving

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Active ingredients
  • Menthol 50 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 2017
Label revision date
November 10, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 50 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 2017
Label revision date
November 10, 2023
Manufacturer
Rexall Sundown, LLC
Registration number
M017
NDC root
59118-837
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful if you are dealing with discomfort related to conditions such as arthritis, simple backaches, strains, bruises, or sprains.

By targeting these specific types of pain, this drug aims to help you feel more comfortable and improve your mobility during everyday activities.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with various conditions, including arthritis, simple backaches, strains, bruises, and sprains.

Whether you've overexerted yourself during physical activity or are experiencing the typical wear and tear of daily life, this medication is designed to ease your pain and help you feel more comfortable. Always remember to follow the recommended guidelines for use.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day. For the best results, it's recommended to use it daily or follow your doctor's instructions. After applying the medication, make sure to wash your hands thoroughly with soap and water to avoid spreading it to other areas.

If you are considering this treatment for a child under 12 years old, it's important to consult a doctor first to ensure it's safe and appropriate for them. Always follow the guidance provided by your healthcare professional for the best outcomes.

What to Avoid

It's important to use this medication safely. You should not apply it to wounds or any damaged, broken, or irritated skin, as this can lead to complications. Additionally, avoid tightly bandaging the area where you apply the medication or using local heat, such as heating patches, as these practices can also cause issues. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to follow the directions carefully. You should avoid contact with your eyes and mucous membranes, and do not apply it to wounds or any broken or irritated skin. If you notice that your condition worsens, symptoms last longer than 7 days, or if irritation develops, you should stop using the product and consult a doctor.

If you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Additionally, keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please use it as directed. Be careful to avoid contact with your eyes and mucous membranes, and do not apply it to any wounds or areas of broken or irritated skin. It's also important not to bandage the area tightly or apply heat, such as heating patches, to the site of application.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience any irritation or excessive irritation, discontinue use and seek medical advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help right away. You can contact a Poison Control Center for guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help immediately. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

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 it to the affected area up to 3 to 4 times a day. For optimal results, daily application or following your doctor’s instructions is recommended.

However, if your child is under 12 years old, you should consult a doctor before use. This ensures that the treatment is safe and appropriate for their age and condition. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 should be used 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

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 have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. For the best results, use it daily or as directed by your doctor. After applying, remember to wash your hands with soap and water. If you are considering using this medication for a child under 12 years old, consult a doctor first.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints associated with conditions like arthritis, simple backache, strains, bruises, and sprains.

How should I apply the drug?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. For best results, apply daily or as directed by a physician.

What should I do after applying the drug?

After applying, wash your hands with soap and water.

Can children use this drug?

Children under 12 years of age should consult a doctor before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I experience irritation?

Discontinue use and consult a doctor if irritation develops or if excessive irritation occurs.

Is it safe to use if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health care professional before use.

What should I do if the drug is swallowed?

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

How should I store the drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Osteo Bi-Flex Joint Health Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Osteo Bi-Flex Joint Health Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Osteo Bi-Flex Joint Health Pain Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and older should apply the medication to the affected area no more than 3 to 4 times daily. For optimal results, it is recommended to apply the medication daily or as directed by a physician.

After each application, it is essential to wash hands thoroughly with soap and water to prevent unintentional exposure to other areas of the body or to others.

For children under 12 years of age, consultation with a doctor is advised prior to use.

Contraindications

The product is contraindicated for application on wounds or damaged, broken, or irritated skin due to the potential for exacerbating the condition. Additionally, it should not be used with tight bandaging or local heat applications, such as heating patches, as these practices may lead to adverse effects in the area of use.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should be used strictly as directed. Care should be taken to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation. It is imperative not to apply the product to wounds or to areas of skin that are damaged, broken, or irritated. Additionally, users should refrain from tightly bandaging the area of application or applying local heat, such as heating patches, to prevent exacerbation of any potential adverse effects.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Furthermore, if irritation develops or excessive irritation occurs, medical advice should be sought promptly.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or to damaged, broken, or irritated skin. Additionally, patients should refrain from tightly bandaging the area of application or applying local heat, such as heating patches.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. Should irritation develop or excessive irritation occur, it is also recommended to seek medical advice.

For pregnant or breastfeeding individuals, it is important to consult a healthcare professional prior to use. Furthermore, this product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Osteo Bi-Flex Joint Health Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Osteo Bi-Flex Joint Health Pain Relieving.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For optimal results, it is recommended to apply the medication daily or as directed by a physician.

For children under 12 years of age, consultation with a doctor is advised prior to use.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data 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 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 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, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. The specific symptoms may vary depending on the substance involved; therefore, a thorough assessment by medical personnel is essential.

Management procedures will typically involve supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous monitoring and evaluation may be necessary to ensure patient safety and effective management of any complications that arise 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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to instruct patients to use the product only as directed to ensure safety and efficacy.

Patients should be cautioned to avoid contact with their eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, they should be informed not to apply the product to wounds or any damaged, broken, or irritated skin to prevent further complications.

Providers should emphasize the importance of not bandaging the area tightly or applying local heat, such as heating patches, to the site of application, as this may exacerbate any potential side effects.

Patients must be advised to discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. They should also be instructed to seek medical advice if symptoms clear up and then recur within a few days. Furthermore, if any irritation develops or excessive irritation occurs, patients should stop using the product and consult a doctor for further evaluation.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with the recommended application frequency for adults and children aged 12 years and older being 3 to 4 times daily. For optimal results, it is advised to apply the product daily or as directed by a physician. After application, patients should wash their hands with soap and water. For children under 12 years of age, consultation with a doctor is recommended prior to use.

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 Osteo Bi-Flex Joint Health Pain Relieving, 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 Osteo Bi-Flex Joint Health Pain Relieving, 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.

Learn more in our Editorial Policy

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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.