Trauma Less

Description

Saje® Natural Wellness Trauma Less is a topical analgesic ointment formulated for localized pain relief. The product is available in two net weights: 1.91 oz (54.1 g) and 0.47 oz (13.5 g). This ointment is designed for external application to alleviate discomfort associated with various conditions.

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 adverse effects. 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 impede circulation and lead to complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from fire or flame to prevent any risk of ignition.

It is imperative that this product not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, individuals with known allergies to plants of the Asteraceae/Compositae/Daisy family should refrain from using this product to avoid potential allergic reactions.

Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to stop using the product 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. These precautions are essential to ensure the safety and efficacy of the treatment.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this product. For adolescents aged 12 years and older, the recommended application is to the affected area no more than three times daily.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. While specific data regarding dosage adjustments or safety considerations for geriatric patients are not provided, it is important to note that the medication is not recommended for children under 12 years of age.

Healthcare providers should exercise caution and closely monitor elderly patients for any potential adverse effects or complications associated with the use of this medication. Regular assessment of the patient's response to treatment and any emerging side effects is advisable to ensure optimal therapeutic outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients, although specific parameters are not defined in the prescribing information.

Overdosage

In the context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering this medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This may include symptomatic treatment and monitoring of vital signs. Healthcare providers should also consider consulting a poison control center or a medical toxicologist for further management recommendations tailored to the specific clinical situation.

Given the lack of specific overdosage information, it is crucial for healthcare professionals to remain vigilant and to document any observed effects in order to contribute to the understanding of the drug's safety profile.

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 this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid its use if they have a known allergy to plants in the asteraceae/compositae/daisy family. It is important for patients to monitor their condition while using the product; they should stop 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.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes while using this product. Patients should also be cautioned against bandaging the area tightly when using the product to ensure proper application 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 whenever possible to support environmental sustainability.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than three times daily for adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, 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)