ADD CONDITION

items per page

Med O-3 Bio-

Last content change checked dailysee data sync status

Active ingredients
  • Capsaicin 0.03 g/100 mL
  • Menthol 1 g/100 mL
  • Methyl Salicylate 10 g/100 mL
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
January 6, 2024
Active ingredients
  • Capsaicin 0.03 g/100 mL
  • Menthol 1 g/100 mL
  • Methyl Salicylate 10 g/100 mL
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
January 6, 2024
Manufacturer
Biological M. D. Solutions LLC
Registration number
M017
NDC root
83538-101

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 fast-acting and deep-penetrating relief for various types of pain. You can use it to help alleviate discomfort associated with conditions such as arthritis, backache, muscle aches, joint pain, sprains, sports injuries, tendon inflammation, and over-use injuries.

With its ability to offer hours of relief, this treatment can be a supportive option for managing pain and improving your comfort in daily activities.

Uses

This medication is designed to provide fast-acting and deep-penetrating relief for various types of pain. If you’re dealing with arthritis, backaches, muscle aches, joint pain, sprains, sports injuries, tendon inflammation, or over-use injuries, this treatment can help you feel better for hours.

You can rely on this product to target your discomfort effectively, allowing you to get back to your daily activities with less pain.

Dosage and Administration

To use this medication effectively, start by applying a generous amount to the area where you feel pain. Once applied, gently massage the product into your skin until it is thoroughly absorbed. You can repeat this process as needed, but do not exceed four applications in a single day.

If you find it helpful, you can also use a wrap over the area after applying the medication. This can provide additional support and comfort while the product works to relieve your pain.

What to Avoid

It's important to use this medication only as directed by your healthcare provider. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always follow your doctor's instructions carefully to ensure safe and effective use. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare professional for guidance.

Side Effects

It's important to be aware of some key warnings associated with this product. It is meant for external use only, so you should avoid contact with your eyes, mucous membranes, and any broken or irritated skin. If your condition worsens, symptoms persist for more than seven days, or if you notice any redness, you should stop using the product and consult a physician. Additionally, this product is not recommended for children under 12 years of age.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes, mucous membranes, or any broken or irritated skin. If your condition worsens, symptoms last more than 7 days, or if you notice any redness, stop using the product and consult your doctor.

It's important to note that this product is not suitable for children under 12 years of age. Always keep it out of reach of children. If the product is swallowed, seek professional help or contact a poison control center immediately. Remember to use it only as directed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you think you or someone else may have taken too much of a medication. Remember, timely intervention can be crucial.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential for ensuring the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

This medication is not recommended for children under 12 years of age. It's important to keep it out of reach of children to prevent accidental ingestion. If a child swallows this medication, you should seek professional help or contact a poison control center right away. Always use this medication only as directed to ensure safety.

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 considering this medication, it’s important to consult with a healthcare provider. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always discuss any new medications, supplements, or changes in your health with your provider. They can help you understand how different treatments may work together and monitor your health effectively. 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 a controlled room temperature between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply the product topically, meaning you will put it directly on your skin. Make sure to apply a generous amount and gently massage it into the painful area until it is fully absorbed. You can repeat this process as needed, but do not exceed four applications in a day. If you prefer, you can also use a wrap with the product for added support.

FAQ

What is the general description of this drug?

This drug is fast acting and deep penetrating.

What conditions does this drug provide relief for?

It provides hours of relief for arthritis, backache, muscle ache, joint pain, sprains, sports injuries, tendon inflammation, and over-use injuries.

How should I apply this drug?

Apply generously and gently massage into the painful area until thoroughly absorbed. You can repeat this up to four times daily.

Are there any warnings I should be aware of?

Yes, this drug is for external use only. Avoid contact with eyes, mucous membranes, and broken or irritated skin. If symptoms persist for more than 7 days or if redness is present, discontinue use and consult a physician.

Is this drug safe for children?

No, it is not for use in children under 12 years of age.

What should I do if this drug is swallowed?

If swallowed, seek professional assistance or call a poison control center immediately.

What is the recommended storage condition for this drug?

Store at controlled room temperature between 59° - 86°F (15° - 30°C).

Packaging Info

Below are the non-prescription pack sizes of Med O-3 Bio- (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Med O-3 Bio-.
Details

Drug Information (PDF)

This file contains official product information for Med O-3 Bio-, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is a 237 mL formulation of 01b LBL_Med 0-3 Bio-Cream. It is designed for topical application and is characterized by its specific formulation intended for medical use. The cream's composition and properties are tailored to meet the needs of patients requiring such a treatment.

Uses and Indications

This drug is indicated for the relief of pain associated with various conditions, including arthritis, backache, muscle ache, joint pain, sprains, sports injuries, tendon inflammation, and over-use injuries. It is characterized by its fast-acting and deep-penetrating properties, providing hours of relief for patients experiencing these types of discomfort.

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

Dosage and Administration

The product should be applied generously to the affected area. After application, it is recommended to gently massage the formulation into the painful area until it is thoroughly absorbed. This process may be repeated as necessary, with a maximum frequency of four times daily. Additionally, the product can be used in conjunction with a wrap for enhanced effect.

Contraindications

There are no contraindications listed for this product. It is essential to use this product only as directed.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes, mucous membranes, and broken or irritated skin. In the event that the condition worsens, symptoms persist for more than 7 days, or if redness is observed, patients should discontinue use and consult a physician.

This product is contraindicated for use in children under 12 years of age. It is imperative to keep the product out of reach of children. In cases of accidental ingestion, immediate professional assistance should be sought, or the local poison control center should be contacted without delay. Patients must be instructed to use the product only as directed to ensure safety and efficacy.

Side Effects

Patients should be aware that the product is for external use only. It is imperative to avoid contact with the eyes, mucous membranes, and broken or irritated skin. In the event that the condition worsens, if symptoms persist for more than 7 days, or if redness is present, patients are advised to discontinue use and consult a physician.

Additionally, this product is not recommended for use in children under 12 years of age.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Med O-3 Bio- (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Med O-3 Bio-.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, professional assistance should be sought immediately, or a poison control center should be contacted. The medication should only be used as directed.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy have been included. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations to ensure optimal patient care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek professional assistance or contact a poison control center immediately. It is essential to emphasize that the medication should be used only as directed to ensure safety and efficacy.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature, maintained between 59°F and 86°F (15°C and 30°C). Care should be taken to ensure that the product is kept within this temperature range to preserve its integrity and efficacy.

Additional Clinical Information

The product is administered topically, with a recommendation to apply generously and gently massage into the painful area until thoroughly absorbed. This application may be repeated as necessary, up to four times daily, and the product can be used in conjunction with a wrap.

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 Med O-3 Bio-, 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 Med O-3 Bio-, 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

Last AI update:

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.