Dakota Muscle Relief Roll-on

Description

Dakota is a roll-on formulation designed for muscle relief, providing fast-acting, all-natural pain relief. This product is specifically indicated for the temporary relief of various conditions, including arthritis, joint pain, back pain, sprains, muscle aches, cramps, congestion, and insect bites. The formulation is non-greasy and features a pleasant scent, enhancing user experience. Each container holds 3 ounces (90 mL) of the product, ensuring convenient application for targeted relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including simple backache, arthritis, sprains, joint pain, bruises, and strains. Additionally, it provides temporary relief from muscle aches, cramps, congestion, and insect bites.

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

Dosage and Administration

For adults and children aged 12 years or older, the product should be shaken well before use. Prior to application, it is recommended to test for skin sensitivity. The spray should be applied directly to the affected area, ensuring that it is not rubbed into the skin. The maximum frequency of application is up to 3 to 4 times per day.

Contraindications

Use of this product is contraindicated in the following situations:

Application of the product should not occur on wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, the use of bandages or heating pads in conjunction with this product is contraindicated, as this may lead to increased risk of adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately to prevent irritation.

Due to the flammable nature of the product, it must be kept away from fire or flame. When utilizing this product, it is essential to adhere strictly to the following guidelines: use only as directed, refrain from bandaging or applying with a heating pad, and avoid application to wounds or damaged skin. Should any irritation develop, the use of the product should be discontinued.

Healthcare professionals should advise patients to stop using the product and consult a physician if the condition worsens, if symptoms persist beyond 7 days, if redness occurs, or if excessive skin irritation develops.

Additionally, this product should be stored out of reach of children. In the case of ingestion, immediate medical assistance should be sought.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only, and contact with the eyes should be avoided. In the event of eye contact, patients should flush the eyes with water immediately.

The product is flammable; therefore, it should be kept away from fire or flame. Patients are advised to discontinue use if any irritation develops. Additionally, they should stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if redness is present, or if excessive skin irritation occurs.

For pregnant or breastfeeding patients, it is recommended to seek advice from a health professional before using this product. Furthermore, the product should be kept out of reach of children, and if ingested, medical help should be sought immediately.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Dakota Muscle Relief Roll-on (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of ingestion, immediate medical assistance is required.

For children aged 12 years and older, the recommended usage involves shaking the product well before application and testing for skin sensitivity. The product should be sprayed directly onto the affected area and applied externally up to a maximum of 3 to 4 times a day. It is important not to rub the area after application.

Geriatric Use

There is no specific information regarding the use of Dakota Muscle Relief Roll-On in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or interactions. It is advisable to consider the overall health status and any comorbidities of geriatric patients when recommending this product.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human 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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required.

Healthcare professionals are advised to assess the situation promptly and initiate appropriate management procedures. Monitoring for potential symptoms associated with overdosage is crucial, although specific symptoms are not detailed in the provided information.

In all cases of suspected overdosage, contacting a poison control center or seeking emergency medical care is recommended to ensure the safety and well-being of 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 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. In the event of ingestion, patients should seek medical help immediately.

Patients should be instructed to stop using the product and consult their doctor if their condition worsens or if symptoms persist for more than 7 days. They should also seek medical advice if they notice any redness or if excessive irritation of the skin develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area or use it in conjunction with a heating pad. Additionally, patients should avoid applying the product to wounds or damaged skin. If any irritation occurs during use, they should discontinue use and consult their healthcare provider.

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 efficacy. Care should be taken to keep the product away from fire or flame to ensure safety during storage. Prior to use, the product must be shaken well to ensure proper mixing of its components.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to 3 to 4 times per day. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children, and if ingested, medical assistance should be sought immediately. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dakota Muscle Relief Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)