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Oxyrub Pro Pain Relief

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This product has been discontinued

Active ingredients
  • Menthol 25.0 mg/1 g
  • Methyl Salicylate 100.0 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
August 15, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 25.0 mg/1 g
  • Methyl Salicylate 100.0 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
August 15, 2017
Manufacturer
Healthy Directions, LLC
Registration number
part348
NDC root
70015-655
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

OxyRub PRO is a professional-strength pain relief cream designed to provide temporary relief from minor aches and pains in your muscles and joints. It is rapidly absorbed and penetrates deeply to help alleviate discomfort associated with conditions like simple backaches, arthritis, strains, sprains, and bruises. This cream is formulated to support your recovery and enhance your comfort during daily activities.

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 backaches, arthritis, strains, sprains, and bruises. This means that if you're dealing with discomfort from these issues, this medication may help ease your pain and improve your mobility.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. If you are caring for a child under 12, it’s important to consult a doctor before using this medication, as they can provide specific advice tailored to your child's needs. Always remember to apply it only to the areas that need treatment.

What to Avoid

It's important to use this product safely to avoid any harmful effects. You should never use it with a heating pad, as this can cause skin blisters. Additionally, avoid applying it on open wounds or damaged skin, as this can lead to further complications.

When using this product, be careful to keep it away from your eyes, and do not wrap or bandage the area tightly. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to follow the directions carefully, as it is meant for external use only. Avoid applying it with a heating pad, as this can cause skin blisters. Do not use it on open wounds or damaged skin, and be cautious if you notice any redness in the area being treated.

If you experience skin redness or excessive irritation, or if your condition worsens or does not improve within 7 days, stop using the product and consult a doctor. Additionally, if symptoms clear up and then return a few days later, seek medical advice. Always keep this product out of reach of children, and if swallowed, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please use it as directed. Avoid using it with a heating pad, as this can cause skin blisters. Do not apply it to open wounds or damaged skin. If you notice any redness in the area you’re treating, consult your doctor before using the product.

While using this product, be careful to keep it away from your eyes and avoid wrapping the area tightly with a bandage. 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 a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

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 doctor before using it, as there may be potential risks to your fetus that are not clearly defined. Caution is advised, and it is generally recommended to avoid using this product during pregnancy unless your healthcare provider specifically directs you to do so.

There are no specific dosage modifications provided for pregnant individuals, so it's crucial to discuss your situation with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can use OxyRub PRO Pain Relief Cream without specific warnings or recommendations against it. Currently, there is no information available about whether the ingredients in this cream pass into breast milk or if they pose any risk to your nursing infant.

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

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 before starting the medication. 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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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.

Additionally, there are no specific interactions noted with other drugs or laboratory tests, but it's still a good practice to keep your healthcare provider informed about all the medications and tests you are undergoing. This way, they can help you avoid any potential issues and provide the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When you need to check important information like the Lot Number and Expiration Date, simply look at the bottom of the carton or the crimp at the end of the tube.

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

Additional Information

No further information is available.

FAQ

What is OxyRub PRO?

OxyRub PRO is a professional strength pain relief cream designed for muscle and joint pain relief. It is rapidly absorbed and deeply penetrating.

What conditions does OxyRub PRO help relieve?

OxyRub PRO temporarily relieves minor aches and pains associated with simple backaches, arthritis, strains, sprains, and bruises.

How should I use OxyRub PRO?

For adults and children 12 years and older, apply to the affected area no more than 3-4 times daily. Children under 12 should consult a doctor.

Are there any contraindications for using OxyRub PRO?

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

What should I do if I experience skin irritation?

Stop use and consult a doctor if skin redness or excessive irritation develops, or if symptoms persist for more than 7 days.

Is OxyRub PRO safe to use during pregnancy?

The safety of OxyRub PRO during pregnancy has not been established. Consult a doctor before use if pregnant or planning to become pregnant.

What precautions should I take when using OxyRub PRO?

Avoid contact with eyes and do not bandage tightly. Keep out of reach of children, and seek medical help if swallowed.

How should I store OxyRub PRO?

Store OxyRub PRO at room temperature. Check the bottom of the carton or crimp at the end of the tube for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Oxyrub Pro Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

OxyRub PRO is a professional strength pain relief cream formulated for the alleviation of muscle and joint pain. This product is designed for rapid absorption and deep penetration, ensuring effective relief at the site of discomfort. Each container holds a net weight of 4 oz (114 g). OxyRub PRO is distributed by Healthy Directions, located at 6710A Rockledge Drive, Suite 500, Bethesda, MD 20817.

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 backaches, 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 dry before applying the medication.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The use of this product is contraindicated in the following situations:

The product should not be applied in conjunction with a heating pad due to the risk of skin blistering. Additionally, it is contraindicated for use on open wounds or damaged skin, as this may exacerbate injury or lead to infection.

Healthcare professionals should also advise patients to avoid contact with the eyes and to refrain from applying tight bandages when using this product.

Warnings and Precautions

For external use only; this product should be utilized strictly as directed to ensure safety and efficacy.

Contraindications This product must not be used in conjunction with a heating pad, as this may lead to skin blistering. Additionally, it is contraindicated for application on open wounds or damaged skin.

Precautions Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

Usage Guidelines While using this product, it is imperative to avoid contact with the eyes. Furthermore, patients should refrain from applying tight bandages over the treated area to prevent complications.

Adverse Reactions Patients should be instructed to discontinue use and seek medical advice if they experience skin redness or excessive irritation. If the condition worsens or symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days, medical consultation is necessary.

Safety Information 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 is recommended.

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 be used strictly as directed. The product should not be applied in conjunction with a heating pad, as this may lead to skin blistering. Additionally, it is contraindicated for use on open wounds or damaged skin.

Before using this product, patients are advised to consult a healthcare professional if there is any redness over the affected area. During application, it is crucial to avoid contact with the eyes and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if they experience skin redness or excessive irritation. Furthermore, if the condition worsens or symptoms persist for more than 7 days, or 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. 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 Oxyrub Pro Pain Relief (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oxyrub Pro Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before 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

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 elderly patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment in elderly patients.

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. No specific dosage modifications for pregnant individuals are provided. It is recommended to avoid use during pregnancy unless directed by a healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of OxyRub PRO Pain Relief Cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance and the severity of the overdosage.

In all cases, the involvement of poison control experts can provide valuable guidance in managing the situation effectively.

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 provided in the insert for OxyRub PRO Pain Relief Cream, 4oz.

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. If symptoms improve and then reoccur within a few days, patients should be instructed to stop use and consult a healthcare professional.

While using the product, patients must be cautioned to avoid contact with their eyes. They should also be advised 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 a carton, with specific Lot Number and Expiration Date information located at the bottom of the carton or on the crimp at the end of the tube. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal quality throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Oxyrub Pro Pain Relief, 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 Oxyrub Pro Pain Relief, 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.