ADD CONDITION
Oprava
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
- Other brand names
- Dendracin Neurodendraxcin (by H. J. Harkins Company, Inc.)
- Dendracin Neurodendraxcin (by Physicians Science & Nature Inc.)
- Dr Demand Relief Pain Relief (by Mind and Body Research Corp)
- Exoten-C (by Asclemed Usa, Inc.)
- Flanax (by Belmora Llc)
- Labella Linimento Obrero (by Golden Sun Inc Dba Newhall Laboratories)
- Lbri Super Aloe Stop the Pain (by L'bris, Pure 'n Natural)
- Limencin (by Alexso, Inc.)
- Med O-3 Bio- (by Biological M. D. Solutions Llc)
- Menthozen (by Village Pharma Llc)
- Menthozen Cream (by Village Pharma Llc)
- Muscular Balm (by Borden Company (private) Limited)
- Muscular Balm (by Eagle Indo Pharma, Pt)
- Neurodexx (by Rely Wellness)
- New Terocin (by Aidarex Pharmaceuticals Llc)
- New Terocin (by Alexso, Inc)
- Nudroxicin Pain Relief Roll-on (by Nucare Pharmaceuticals Inc)
- Overtime (by Physicians Science & Nature Inc.)
- Rematex (by Home Aide Diagnostics, Inc.)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fire (by Ningbo Sante Ying Medicaland Healthdevelopment Co. , Ltd)
- Rocksauce Fire (by Ningbo Sante Ying Medicaland Healthdevelopment Co. , Ltd)
- Rotex (by Home Aide Diagnostics, Inc.)
- Topical (by Two Hip Consulting, Llc)
- Vitacin (by Mas Management Group Inc.)
- Xoten-C (by Living Well Pharmacy Inc.)
- Zensezone Arthmed Temporary Pain Relief Cream (by Zensezone Llc)
- Ziks Arthritis Pain Relief (by Nnodum Pharmaceuticals)
- View full label-group details →
- 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 2023
- Label revision date
- January 6, 2024
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Capsaicin 0.03 g/100 mL
- Menthol 1 g/100 mL
- Methyl Salicylate 10 g/100 mL
- Other brand names
- Dendracin Neurodendraxcin (by H. J. Harkins Company, Inc.)
- Dendracin Neurodendraxcin (by Physicians Science & Nature Inc.)
- Dr Demand Relief Pain Relief (by Mind and Body Research Corp)
- Exoten-C (by Asclemed Usa, Inc.)
- Flanax (by Belmora Llc)
- Labella Linimento Obrero (by Golden Sun Inc Dba Newhall Laboratories)
- Lbri Super Aloe Stop the Pain (by L'bris, Pure 'n Natural)
- Limencin (by Alexso, Inc.)
- Med O-3 Bio- (by Biological M. D. Solutions Llc)
- Menthozen (by Village Pharma Llc)
- Menthozen Cream (by Village Pharma Llc)
- Muscular Balm (by Borden Company (private) Limited)
- Muscular Balm (by Eagle Indo Pharma, Pt)
- Neurodexx (by Rely Wellness)
- New Terocin (by Aidarex Pharmaceuticals Llc)
- New Terocin (by Alexso, Inc)
- Nudroxicin Pain Relief Roll-on (by Nucare Pharmaceuticals Inc)
- Overtime (by Physicians Science & Nature Inc.)
- Rematex (by Home Aide Diagnostics, Inc.)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fiery Hot Pain Relief (by Implus Footcare, Llc)
- Rocksauce Fire (by Ningbo Sante Ying Medicaland Healthdevelopment Co. , Ltd)
- Rocksauce Fire (by Ningbo Sante Ying Medicaland Healthdevelopment Co. , Ltd)
- Rotex (by Home Aide Diagnostics, Inc.)
- Topical (by Two Hip Consulting, Llc)
- Vitacin (by Mas Management Group Inc.)
- Xoten-C (by Living Well Pharmacy Inc.)
- Zensezone Arthmed Temporary Pain Relief Cream (by Zensezone Llc)
- Ziks Arthritis Pain Relief (by Nnodum Pharmaceuticals)
- View full label-group details →
- 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 2023
- Label revision date
- January 6, 2024
- Manufacturer
- Biological M. D. Solutions LLC
- Registration number
- M017
- NDC root
- 83538-102
- Drug Information (PDF)
- Prescribing information, PDF file
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 temporarily relieve discomfort associated with arthritis, muscle pain, and inflammation. By targeting these specific issues, it helps to ease your pain and improve your overall comfort. If you're experiencing any of these conditions, this drug may provide the relief you need to feel better.
Uses
You can use this medication to temporarily relieve discomfort caused by arthritis, muscle pain, and inflammation. Whether you're dealing with chronic joint issues or occasional muscle soreness, this treatment can help ease your symptoms and improve your comfort.
It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause developmental problems in a fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.
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. Remember to listen to your body and adjust the frequency of application based on your comfort and needs.
What to Avoid
It's important to keep this product out of reach of children. If a child accidentally swallows it, seek professional help or contact a poison control center right away. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it responsibly and as directed.
Side Effects
When using this product, it's important to be aware of some potential side effects and warnings. This medication is for external use only, so 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, and you should always use it as directed.
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. It’s important to use the product exactly as directed and to keep it out of reach of children. If you are caring for a child under 12 years of age, do not use this product on them.
If your condition worsens, if symptoms last more than 7 days, or if you notice any redness, stop using the product and consult your doctor. In case of accidental swallowing, seek professional help or contact a poison control center immediately. Your safety is important, so please take these precautions seriously.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 checked by a healthcare professional if you have any concerns about your health.
Pregnancy Use
While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is important to approach any medication with care. There are no dosage modifications recommended for pregnant individuals, which suggests that the standard dosing may be considered safe. However, since the insert does not address pregnancy use directly, it is always best to consult with your healthcare provider before taking any medication if you are pregnant or planning to become pregnant. They can provide personalized advice based on your specific situation.
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.
As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.
Pediatric Use
It's important to know that this medication is not recommended for children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that may be more suitable for their needs. Always prioritize safety and follow your doctor's guidance when it comes to treating your child's health.
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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.
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 differently due to your liver health.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.
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.
By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.
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 to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.
Additional Information
You should apply the medication topically, which means putting it directly on the 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 up to four times a day as needed.
FAQ
What conditions does this drug temporarily relieve?
This drug temporarily relieves arthritis, muscle pain, and inflammation.
How should I apply this drug?
You should apply it generously and gently massage it into the painful area until thoroughly absorbed. Repeat as necessary, up to four times daily.
Is this drug safe to use during pregnancy?
There are no specific safety concerns or dosage modifications mentioned for use during pregnancy.
Can this drug be used by children?
This drug is not for use in children under 12 years of age.
What precautions should I take when using this drug?
Use only as directed, avoid contact with eyes and broken skin, and discontinue use if the condition worsens or symptoms persist for more than 7 days.
What should I do if this drug is swallowed?
Keep it out of reach of children. If swallowed, seek professional assistance or call a poison control center immediately.
What is the storage requirement 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 Oprava (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cream |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Oprava, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
This product is presented in a dosage form of 237 mL. The principal display panel (PDP) and detailed formulation images (DF1 and DF2) are available for reference. The effective date of this labeling is August 8, 2023. The product is identified by the code 51945-4 within the relevant code system. The images associated with the product include a JPEG format representation of the PDP and two additional JPEG images detailing the formulation.
Uses and Indications
This drug is indicated for the temporary relief of arthritis, muscle pain, and inflammation.
There are no teratogenic or nonteratogenic effects associated with this drug.
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 up to four times daily. Additionally, the product can be used in conjunction with a wrap to enhance its effectiveness.
Contraindications
Use is contraindicated in individuals who are unable to keep the product out of reach of children. In the event of accidental ingestion, immediate professional assistance or contact with a poison control center is required.
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 any broken or irritated skin to prevent adverse reactions.
In cases where the condition worsens, or if symptoms persist for more than 7 days, or if redness is observed, it is imperative to discontinue use and consult a physician for further evaluation and management.
The product should be used strictly as directed. It is contraindicated for use in children under 12 years of age, and healthcare providers should ensure that this information is communicated effectively to caregivers.
Additionally, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate professional assistance should be sought, or a poison control center should be contacted without delay.
Side Effects
Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only and should not come into contact with the eyes, mucous membranes, or broken or irritated skin. If 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 should be used only as directed and is not recommended for use in children under 12 years of age.
Drug Interactions
There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.
Packaging & NDC
Below are the non-prescription pack sizes of Oprava (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cream |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients under 12 years.
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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.
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, nor are there any special precautions regarding its use during pregnancy. 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 nursing 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.
Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.
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 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. This information is crucial for ensuring the safety of both patients and their families.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.
Additional Clinical Information
The product is administered topically, with a recommendation to apply generously to the affected area. Clinicians should instruct patients to gently massage the application into the painful area until it is thoroughly absorbed. This process may be repeated as necessary, with a maximum frequency of four times daily.
No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.
Drug Information (PDF)
This file contains official product information for Oprava, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.