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Doloflex Pain Relief

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Active ingredients
  • Menthol 2 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Gel
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 2025
Label revision date
October 12, 2025
Manufacturer
United Health & Beauty Corp
Registration number
M017
NDC root
85350-039
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

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, strains, sprains, and bruises. If you're experiencing discomfort from these issues, this drug may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, sprains, and bruises. This means if you're dealing with discomfort from these issues, this medication may help ease your pain and improve your comfort.

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

Dosage and Administration

If you are 12 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this schedule to help manage your symptoms effectively.

If you are caring for a child under 12, it’s important to consult a physician (doctor) before using this medication. They can provide guidance on the appropriate treatment for younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help or contact a poison control center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. This product is for external use only and should not be applied to children under 12 years of age, on wounds, or damaged skin. Avoid using it with a heating pad, as this may cause skin blisters. While using the product, do not bandage tightly and keep it away from your eyes and mucous membranes.

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

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. It’s important not to use it on children under 12 years old, on wounds, or on damaged skin. Additionally, do not use it with a heating pad, as this may cause skin blisters. When applying, make sure not to bandage tightly.

If you experience excessive irritation, if your symptoms last more than 7 days, or if your condition worsens or returns shortly after improvement, stop using the product and consult your doctor. In case of accidental swallowing, seek medical help or contact a poison control center immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Doloflex Pain Relief (menthol, methyl salicylate gel) during pregnancy has not been established. There may be potential risks to your fetus, so you should approach the use of this product with caution. Always consult your physician before using Doloflex or any similar products to ensure they are safe for you and your baby.

Currently, there are no specific dosage modifications provided for pregnant individuals. Therefore, it's best to seek guidance from a healthcare professional regarding the use of this medication during your pregnancy. Your health and the health of your baby are the top priority, so make informed decisions with your doctor.

Lactation Use

If you are breastfeeding, you can use Doloflex Pain Relief without specific warnings or recommendations against it. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risks to your nursing infant.

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

Pediatric Use

It's important to be cautious when considering this medication for children. You should not use it on children under 12 years of age. If your child is under 12, it's best to consult a physician (a medical doctor) for guidance.

For those aged 12 and older, you can apply the medication to the affected area up to 3 to 4 times a day. Always follow the recommended guidelines to ensure safety and effectiveness.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 related to 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 plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can use this product for external application on affected areas up to 3 to 4 times daily if you are an adult or a child aged 12 years or older. If your child is under 12, it's important to consult a physician before use. Remember, this product is for external use only, so avoid applying it to wounds, damaged skin, or using it with a heating pad, as this may cause skin blisters.

Be cautious not to bandage the area tightly and keep it away from your eyes and mucous membranes. If you experience excessive irritation, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. In case of accidental ingestion, seek medical help or contact a poison control center immediately.

FAQ

What conditions does this drug relieve?

The drug temporarily relieves minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, sprains, and bruises.

How should I use this drug?

Adults and children 12 years of age or older should apply it to the affected area up to 3 to 4 times daily. For children under 12 years, consult a physician.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but do not use on children under 12 years of age, on wounds or damaged skin, or with a heating pad.

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a poison control center right away.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and there may be potential risks to the fetus. Consult a physician if pregnant or planning to become pregnant.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers.

What precautions should I take while using this drug?

For external use only. Avoid contact with eyes or mucous membranes, do not bandage tightly, and stop use if excessive irritation develops or symptoms persist.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Doloflex Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including 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 up to three to four times daily. The specific frequency of application may be adjusted based on the severity of the condition and the clinical response observed.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate dosage and administration tailored to the child's needs.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, immediate medical assistance should be sought or a poison control center contacted.

Warnings and Precautions

For external use only. This product is contraindicated in children under 12 years of age and should not be applied in conjunction with a heating pad, as this may lead to skin blistering. It is also advised against using this product on wounds or damaged skin.

When utilizing this product, it is imperative to avoid tight bandaging and to prevent contact with the eyes or mucous membranes. In the event of excessive irritation, prolonged symptoms lasting more than 7 days, recurrence of symptoms after initial improvement, or worsening of the condition, the user should discontinue use and consult a healthcare professional.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to children under 12 years of age. It is contraindicated for use in conjunction with a heating pad, as this may lead to skin blistering. Additionally, the product should not be applied to wounds or damaged skin.

While using this product, patients are advised to avoid tight bandaging and to prevent contact with the eyes or mucous membranes. In the event of excessive irritation, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. Furthermore, if the condition worsens, it is imperative to seek medical advice promptly.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Doloflex Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For children in this age group, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the recommended application is to the affected area up to 3 to 4 times daily.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of Doloflex Pain Relief (menthol, methyl salicylate gel) during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician before use. There may be potential risks to the fetus; therefore, the use of this product during pregnancy should be approached with caution. No specific dosage modifications for pregnant individuals are provided; healthcare professionals should be consulted for guidance regarding use in this population.

Lactation

There are no specific warnings or recommendations regarding the use of Doloflex Pain Relief in lactating mothers. Additionally, there is no information available about the potential for excretion of Doloflex Pain Relief 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a poison control center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with swallowing the medication.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area up to 3 to 4 times daily. For children under 12 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients that the product is for external use only and should not be applied to children under 12 years, on heating pads (to prevent skin blistering), or on wounds or damaged skin. Patients should avoid tight bandaging, contact with eyes or mucous membranes, and should discontinue use and consult a doctor if excessive irritation occurs, symptoms persist beyond 7 days, or if the condition worsens or recurs shortly after improvement. In the event of ingestion, patients should seek medical assistance or contact a poison control center immediately.

Drug Information (PDF)

This file contains official product information for Doloflex 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 Doloflex 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.