Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Analgesic

Last content change checked dailysee data sync status

Active ingredient
Menthol 70 mg/1 L
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 2018
Label revision date
October 1, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 70 mg/1 L
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 2018
Label revision date
October 1, 2018
Manufacturer
Safetec of America, Inc.
Registration number
part348
NDC root
61010-8202
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

Safetec Pain Relief Roll-On is a medicated product designed to provide fast-acting, temporary relief from minor aches and pains in your muscles and joints. This convenient roll-on application makes it easy to target specific areas of discomfort, helping you feel more comfortable throughout your day.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It’s designed to help you feel more comfortable when dealing with these everyday discomforts.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing your minor pain.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 2 years or older, you can apply it to the affected area up to 3 to 4 times a day. This means you can use it several times throughout the day, but be careful not to exceed this limit.

If you have a child who is under 2 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use for younger children. Always follow these instructions to ensure safe and effective treatment.

What to Avoid

If you experience excessive skin irritation or have a history of allergic reactions to salicylates (a group of compounds that includes aspirin), it's important to consult your doctor before using this product.

To ensure your safety, do not apply it to open wounds or damaged skin, and avoid tightly bandaging the area. If your condition worsens, or if symptoms last more than 7 days or improve only to return shortly after, stop using the product and seek medical advice.

Side Effects

You should be aware that this product is for external use only and is flammable, so keep it away from flames. If you accidentally swallow it, seek medical help or contact a poison control center immediately. Avoid getting it in your eyes, and do not apply it to open wounds or damaged skin. It's important not to bandage the area tightly.

If you experience excessive skin irritation or have a history of allergic reactions to salicylates (like aspirin), consult your doctor. Additionally, if your condition worsens, if symptoms last more than 7 days, or if they improve and then come back within a few days, stop using the product and talk to your doctor.

Warnings and Precautions

This product is for external use only and is flammable, so be sure to keep it away from any flames. If you accidentally swallow it, seek medical help or contact a poison control center immediately. Avoid getting it in your eyes, and do not apply it to open wounds or damaged skin. When using the product, do not bandage the area tightly.

If you experience excessive skin irritation or have a history of allergic reactions to salicylates (like aspirin), consult your doctor. Additionally, if your condition worsens, if symptoms last more than 7 days, or if they clear up and then come back within a few days, stop using the product and reach out to your doctor for further advice.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately or contact a poison control center. Acting quickly can make a significant difference in managing the situation.

Signs of an overdose can vary, but they may include unusual symptoms that require attention. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that this product has not been evaluated for safety during pregnancy. 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 best to discuss your options with your doctor.

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

When using this medication for children aged 2 years and older, you should shake the bottle well before applying it to the affected area. It can be used up to 3-4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use to ensure safety and proper guidance. Always follow these recommendations to help keep your child safe and healthy.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your healthcare provider if you have a history of allergic reactions to salicylates, such as aspirin. This is crucial to ensure your safety and to avoid any potential complications with your medications.

While there are no specific interactions with laboratory tests noted, discussing all your medications and any tests you may undergo with your healthcare provider is always a good practice. This helps ensure that you receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use.

If you have any questions about disposal or specific handling techniques, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Safetec Pain Relief Roll-On used for?

Safetec Pain Relief Roll-On is used for the temporary relief of minor aches and pains of muscles and joints.

How should I use Safetec Pain Relief Roll-On?

For adults and children 2 years of age and older, shake well and apply to the affected area not more than 3-4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using this product?

Consult a doctor if excessive skin irritation occurs or if you are prone to allergic reactions to salicylates, including aspirin. Do not apply to open wounds or damaged skin.

What should I do if I experience worsening symptoms?

If your condition worsens, if symptoms persist for more than 7 days, or if they clear up and recur within a few days, discontinue use and consult a doctor.

Is Safetec Pain Relief Roll-On safe to use during pregnancy?

The product has not been evaluated for safety during pregnancy, so it is recommended to avoid use unless directed by a healthcare provider.

Can I use Safetec Pain Relief Roll-On while nursing?

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

What precautions should I take when using this product?

For external use only; it is flammable, so keep it away from flame. Avoid contact with eyes and do not bandage tightly.

What should I do if I accidentally swallow the product?

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

Packaging Info

Below are the non-prescription pack sizes of Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Safetec Pain Relief Roll-On is a medicated formulation designed for the temporary relief of minor aches and pains. This fast-acting product is packaged in a 3 fluid ounce (88 ml) container. The National Drug Code (NDC) for this product is 61010-XXXX-X, and it is identified by reorder number 58001.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the product should be shaken well before use. It is to be applied to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients with a known allergy to salicylates, including aspirin, due to the risk of allergic reactions.

  • Application to open wounds or damaged skin is prohibited to prevent exacerbation of the condition.

  • Tight bandaging is not recommended as it may lead to increased irritation or complications.

If excessive skin irritation occurs, or if the condition worsens, symptoms persist for more than 7 days, or clear up and recur within a few days, discontinue use and consult a healthcare professional.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from open flames and other sources of ignition.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local poison control center should be contacted without delay. Care should be taken to avoid contact with the eyes, as this may lead to irritation or injury.

Application of this product is contraindicated on open wounds or damaged skin. Additionally, it is advised not to apply a tight bandage over the treated area to prevent complications.

Healthcare professionals should be vigilant for signs of excessive skin irritation. If such reactions occur, or if the patient has a known history of allergic reactions to salicylates, including aspirin, consultation with a physician is recommended.

Patients should be instructed to discontinue use of the product if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, a healthcare provider should be consulted for further evaluation and management.

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 is flammable; therefore, it should be kept away from flames. In the event of accidental ingestion, patients are advised to seek medical help or contact a poison control center immediately.

Contact with the eyes should be avoided, and the product should not be applied to open wounds or damaged skin. Additionally, it is important not to bandage the area tightly after application. Patients who experience excessive skin irritation or have a known sensitivity to salicylates, including aspirin, should consult a doctor prior to use.

If the condition being treated worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of the product and seek medical advice.

Drug Interactions

Patients with a known hypersensitivity to salicylates, including aspirin, should consult a healthcare professional prior to initiating treatment. This precaution is essential to avoid potential allergic reactions.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, it is always advisable for patients to inform their healthcare provider of all medications and supplements they are taking to ensure comprehensive care.

Packaging & NDC

Below are the non-prescription pack sizes of Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Analgesic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking well and applying it to the affected area no more than 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. Therefore, pregnant patients or those planning to become pregnant should consult a healthcare provider before use. While potential risks to the fetus are not specified, caution is advised. There are no specific dosage modifications for pregnant individuals. 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 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

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to instruct patients to avoid contact with their eyes to prevent irritation or injury.

Healthcare providers should emphasize that the product should not be applied to open wounds or damaged skin, and patients should be cautioned against tightly bandaging the area where the product is applied.

Patients should be informed to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, they should be advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Analgesic, 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 Analgesic, 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.