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Trauma Less

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Active ingredient
Menthol 12.7 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
October 5, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 12.7 mg/1 g
Other brand names
Dosage form
Ointment
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 2016
Label revision date
October 5, 2023
Manufacturer
Saje Natural Business Inc.
Registration number
M017
NDC root
70983-009
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

Trauma Less is a topical analgesic ointment produced by Saje® Natural Wellness. It is designed to provide relief from discomfort in specific areas of the body. This product is suitable for use by adults and children aged 12 years and older, making it a versatile option for those seeking pain relief.

You can apply Trauma Less directly to the affected area to help alleviate pain and discomfort. With options available in different sizes, it can be convenient to have on hand for various needs.

Uses

You can use this medication to treat affected areas on your skin if you are an adult or a child aged 12 years and older. Simply apply it directly to the area that needs attention.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication. This makes it a safe option for those who need it.

Dosage and Administration

You should take this medication no more than three times a day. It's important to follow this guideline to ensure your safety and the effectiveness of the treatment. If you are considering this medication for a child, please note that it is not recommended for anyone under the age of 12. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

You should avoid using this product if you are allergic to plants in the asteraceae/compositae/daisy family. Additionally, it is important not to apply it on wounds or damaged skin, as this can lead to irritation or complications. Be careful to keep it away from your eyes, and do not bandage the area tightly after application, as this can restrict blood flow and cause further issues. Always prioritize your safety and well-being when using any medical product.

Side Effects

You should be aware that this product is for external use only and is flammable, so it's important to keep it away from fire or flames. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor.

No specific adverse reactions or side effects have been reported for this product, but it's always good to stay vigilant and monitor how you feel while using it.

Warnings and Precautions

This product is intended for external use only, so please avoid using it on any internal areas. It is also flammable, so be sure to keep it away from fire or flames to prevent any accidents.

If you accidentally swallow the product, seek emergency medical help immediately or contact a Poison Control Center. Additionally, if your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and call your doctor for further guidance.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but it’s important to be aware of any unusual symptoms you may experience.

In the event of an overdose, do not wait for symptoms to worsen. Prompt action can make a significant difference in your health and safety. Always prioritize getting professional assistance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

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 who is 12 years or older, you can apply it to the affected area, but make sure to do so no more than three 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 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 change 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 adjustments to your medications.

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 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 care for your product, please remember to recycle it whenever possible. This helps reduce waste and supports environmental sustainability. Proper disposal is an important part of handling your device safely, so always check local recycling guidelines to see how you can contribute. By taking these simple steps, you can help protect both your health and the planet.

Additional Information

You should apply this medication topically to the affected area, no more than three times a day for adults and children aged 12 and older. If you are pregnant or breastfeeding, it's important to consult your doctor before using this product. Additionally, if your condition worsens, or if symptoms last longer than seven days or return shortly after improvement, you should stop using the medication and seek medical advice.

FAQ

What is Trauma Less?

Trauma Less is a topical analgesic ointment manufactured by Saje® Natural Wellness.

Who can use Trauma Less?

Trauma Less is indicated for adults and children 12 years of age and older. It is not recommended for children under 12.

How should I apply Trauma Less?

Apply Trauma Less to the affected area not more than 3 times daily.

Are there any contraindications for using Trauma Less?

Do not use Trauma Less if you are allergic to plants of the asteraceae/compositae/daisy family.

What should I avoid while using Trauma Less?

Avoid using Trauma Less on wounds or damaged skin, contact with the eyes, and do not bandage tightly.

What should I do if my condition worsens?

Stop using Trauma Less and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or return after clearing up.

Is Trauma Less safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a doctor before using Trauma Less.

What are the warnings associated with Trauma Less?

Trauma Less is for external use only and is flammable, so keep it away from fire or flame.

What should I do if I accidentally swallow Trauma Less?

If Trauma Less is swallowed, get medical help or contact a Poison Control Center immediately.

What sizes are available for Trauma Less?

Trauma Less is available in two net weight options: 1.91 oz (54.1 g) and 0.47 oz (13.5 g).

Packaging Info

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

Packaging configurations for Trauma Less.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Trauma Less Topical Analgesic Ointment is a product offered by Saje® Natural Wellness. It is available in two net weight options: 1.91 ounces (54.1 grams) and 0.47 ounces (13.5 grams). The formulation is designed for topical application to provide analgesic effects.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older.

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

Dosage and Administration

The recommended dosage for the medication is to administer it no more than three times daily. It is important to note that this medication is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that the dosing frequency does not exceed the specified limit to maintain safety and efficacy.

Contraindications

Use is contraindicated in individuals with a known allergy to plants of the Asteraceae/Compositae/Daisy family due to the potential for severe allergic reactions.

The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Contact with the eyes must be avoided to prevent irritation or injury. Additionally, tight bandaging of the area where the product is applied is contraindicated, as it may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Patients should discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and intervention as needed.

Side Effects

For external use only. Patients are advised to keep the product away from fire or flame due to its flammable nature.

Patients should 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 occur again within a few days.

No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences.

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 Trauma Less (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Trauma Less.
Details

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this medication. For adolescents aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than three 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 these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare professionals should be prepared to provide comprehensive information regarding the substance involved and the circumstances of the overdose to facilitate appropriate management and treatment.

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 available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin to prevent potential complications.

Patients should be informed that the product should not be used if they have a known allergy to plants in the asteraceae/compositae/daisy family. Providers should emphasize the necessity of discontinuing use and consulting a doctor if the patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, healthcare providers should remind patients to avoid contact with the eyes while using this product. It is also crucial to advise patients against tightly bandaging the area where the product is applied to ensure proper healing and minimize the risk of adverse effects.

Storage and Handling

The product is available in various packaging configurations, with specific NDC numbers provided for identification. It is essential to store the product under appropriate conditions to maintain its integrity and efficacy.

Storage should be conducted in a controlled environment, ensuring that the temperature remains within the specified range. Containers must be kept sealed and protected from light and moisture to prevent degradation.

Special handling requirements include adherence to recycling protocols; healthcare professionals are encouraged to recycle packaging materials where possible to support environmental sustainability.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to three times daily for adults and children aged 12 years and older. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. Patients are also instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist beyond seven days, or if symptoms resolve and then recur within a few days.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Trauma Less, 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 Trauma Less, 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.