Dakota Muscle Relief

Description

Dakota is a spray-on formulation designed for muscle relief, available in an 8 oz. (240 ml) volume. This product is characterized by its fast-acting properties, non-greasy texture, and pleasant scent. Dakota provides temporary relief from various conditions, including arthritis, joint pain, back pain, sprains, muscle aches, cramps, congestion, and insect bites.

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 or adverse reactions. Additionally, the use of bandages or heating pads in conjunction with this product is contraindicated, as this may alter its effectiveness or lead to unwanted 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.

The product should be kept away from fire or flame to prevent any potential hazards. When utilizing this product, it is essential to adhere strictly to the directions provided. Bandaging or the use of a heating pad in conjunction with this product is not recommended. Additionally, it should not be applied to wounds or damaged skin. If any irritation develops during use, the application should be discontinued.

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

It is crucial to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought.

Side Effects

Patients using this product should be aware of several important safety considerations. This product is for external use only, and contact with the eyes should be avoided. In the event of eye contact, it is imperative to flush the eyes with water immediately. The product is flammable; therefore, it should be kept away from fire or flame.

During use, patients are advised to discontinue the product if any irritation develops. Additionally, patients should stop use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, particularly if redness is present or if excessive skin irritation occurs.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Furthermore, this product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

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 Dakota Muscle Relief (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. The product is indicated for use in adults and children aged 12 years or older, and specific dosing instructions should be followed as outlined in the directions for use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Dakota Muscle Relief, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of clinical data specifically addressing the geriatric population, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or changes in efficacy. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment in this demographic.

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 the safety of both the mother and the fetus or 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 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 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 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 should be vigilant for potential symptoms associated with overdosage, which may vary depending on the specific substance involved. Prompt recognition of these symptoms is crucial for effective management.

Management of overdosage typically involves supportive care and symptomatic treatment. It is essential to assess the patient's condition and provide appropriate interventions based on the severity of symptoms and the specific circumstances of the overdose.

In all cases of suspected overdosage, contacting a poison control center or seeking emergency medical care is strongly 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 use of the compound in these contexts.

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. Additionally, they should 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. It is also important to inform patients not to apply the product to wounds or damaged skin. If any irritation occurs during use, patients should discontinue use and consult their healthcare provider.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety. Prior to use, the product must be shaken well to ensure proper consistency and effectiveness.

For optimal handling, it is important to avoid bandaging the area after application or using a heating pad in conjunction with the product. Additionally, the product should not be applied to wounds or damaged skin to prevent adverse effects.

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 experiences.

Drug Information (PDF)

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

View product document (PDF)