ADD CONDITION

items per page

Pain Relieving

Last content change checked dailysee data sync status

Active ingredient
Menthol, Unspecified Form 7 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
February 5, 2024
Active ingredient
Menthol, Unspecified Form 7 g/100 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
February 5, 2024
Manufacturer
Safetec of America, Inc.
Registration number
M017
NDC root
61010-1560

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 is a pain-relieving spray designed to provide fast-acting relief for minor aches and pains in your muscles and joints. This topical analgesic contains natural ingredients like Tea Tree and Eucalyptus Oils, which contribute to its soothing effects.

You can use Safetec to help alleviate discomfort from everyday activities or minor injuries, making it a convenient option for quick muscle relief.

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 known 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 potential risks.

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 amount.

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 best course of action for your child's specific needs. Always follow these instructions to ensure safe and effective use of the medication.

What to Avoid

If you are prone to allergic reactions to salicylates, such as aspirin, it’s important to consult your doctor before using this medication. Additionally, you should avoid applying it to open wounds or damaged skin, as this can lead to complications. When using the product, do not bandage the area tightly, as this may cause further issues.

Always prioritize your safety by following these guidelines to prevent any adverse effects. If you have any concerns or questions, don’t hesitate to reach out to your healthcare provider for more information.

Side Effects

This product is for external use only and is flammable, so please handle it with care. 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 please keep it away from heat or flames. Avoid getting it in your eyes, and do not apply it to open wounds or damaged skin. If you accidentally swallow the product, seek medical help or contact a poison control center immediately.

If you experience excessive skin irritation or have a history of allergic reactions to salicylates (a group of medications that includes aspirin), consult your doctor before using this product. 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 reach out to your doctor for further advice.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

Currently, there is no information available about the use of Pain Relieving Spray during pregnancy. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the safest options for pain relief during this time. Always prioritize your health and the health of your baby when considering any medication.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

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’s important to limit the application to no more than 3 to 4 times a day.

If your child is under 2 years old, it’s essential to consult a doctor before use to ensure safety and proper guidance. Always prioritize your child's health by following these recommendations closely.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

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 be adjusted 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 changes to your medications.

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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. This helps maintain its effectiveness and integrity. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Safetec?

Safetec is a fast-acting pain relieving spray that provides temporary relief of minor aches and pains of muscles and joints.

What are the active ingredients in Safetec?

Safetec contains Tea Tree and Eucalyptus Oils as part of its formulation.

How should I use Safetec?

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 Safetec?

Yes, consult a doctor if you are prone to allergic reactions to salicylates, including aspirin.

What precautions should I take when using Safetec?

Do not apply to open wounds or damaged skin, and avoid contact with eyes. It is for external use only and is flammable.

What should I do if I swallow Safetec?

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

What should I do if my condition worsens or symptoms persist?

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

Is Safetec safe to use during pregnancy?

There is no specific information regarding the use of Safetec during pregnancy.

Can nursing mothers use Safetec?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

How should Safetec be stored?

Store Safetec at room temperature.

Packaging Info

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

Packaging configurations for Pain Relieving.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Safetec is a fast-acting topical analgesic formulated as a pain-relieving spray. It contains Tea Tree and Eucalyptus Oils, which contribute to its muscle relief properties. The product is available in a volume of 4 fluid ounces (118.3 milliliters) and is classified as a topical analgesic. The reorder number for this product is 58004.

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.

In the case of children under 2 years of age, it is advised to consult a healthcare professional prior to administration.

Contraindications

Use is contraindicated in patients with a known hypersensitivity to salicylates, including aspirin, due to the potential for severe allergic reactions.

Application is contraindicated on open wounds or damaged skin to prevent irritation and adverse effects. Additionally, tight bandaging of the area should be avoided to ensure proper circulation and prevent complications.

Warnings and Precautions

This product is intended for external use only and is flammable. It is imperative to avoid contact with the eyes. In the event of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

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. Healthcare professionals should be aware that excessive skin irritation may occur; in such cases, or if the patient has a known sensitivity to salicylates, including aspirin, consultation with a physician is recommended.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Regular monitoring of the patient's response to treatment is advised to ensure safety and efficacy.

Side Effects

Patients should be aware that the product is for external use only and is flammable. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

It is important to avoid contact with the eyes and to refrain from applying the product to open wounds or damaged skin. Bandaging should not be done tightly over the application site. Patients are also advised to consult a healthcare professional if excessive skin irritation occurs or if they have a history of allergic reactions to salicylates, including aspirin.

In clinical use, if the condition 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

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Pain Relieving.
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 children under 2 years of age, it is advised to consult a doctor prior to use.

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, given the lack of targeted data.

Pregnancy

There is no information available regarding the use of Pain Relieving Spray during pregnancy. Healthcare professionals should exercise caution when prescribing this medication to pregnant patients, as the potential risks and effects on fetal outcomes are not established. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider before using this product.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals should exercise caution when recommending this product to nursing mothers.

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 event of an overdosage, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a poison control center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

It is imperative that healthcare providers remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary, following established protocols for overdose management.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product away from flames and out of reach of children to ensure safety. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be cautioned to avoid contact with their eyes and not to apply the product to open wounds or damaged skin. It is important to inform patients that they should not bandage the area tightly after application.

Healthcare providers should recommend that patients consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, patients should be instructed 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 available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pain Relieving, 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 Pain Relieving, 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.