Natureplex Extra Strength Muscle Rub

Description

The product identified by SPL Code 34089-3 is characterized by its fast-penetrating formulation designed to provide effective pain relief. It is indicated for the alleviation of various types of pain, including arthritis pain, backache, muscle pain, and joint pain.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including simple backache, arthritis, strains, bruises, and sprains. It provides fast-penetrating pain relief specifically targeting arthritis pain, backache, muscle pain, and joint pain.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area up to 3 to 4 times daily. The frequency of application may be adjusted based on the severity of the condition and the response to treatment.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Contraindications

The use of this product is contraindicated in patients with wounds or damaged skin due to the potential for adverse effects and impaired healing.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. The application of this product on wounds or damaged skin is contraindicated, as it may exacerbate the condition or lead to adverse effects.

When utilizing this product, it is essential not to apply a tight bandage over the treated area, as this may interfere with the product's efficacy and increase the risk of irritation.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: excessive irritation develops, the condition worsens, or symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

For individuals who are pregnant or breastfeeding, it is crucial to consult a healthcare professional prior to use to ensure safety for both the mother and child.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised at 800-222-1222.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and awareness. The product is intended for external use only, and contact with eyes and mucous membranes should be avoided to prevent irritation. It is contraindicated for use on wounds or damaged skin, as this may exacerbate adverse effects.

During the use of this product, patients are advised not to bandage the area tightly, as this could lead to increased irritation or other complications. Should excessive irritation develop, or if the condition worsens or symptoms persist for more than 7 days, patients should discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, it is recommended to seek medical advice.

Special considerations should be taken for pregnant or breastfeeding individuals; they are encouraged to consult a health professional prior to use. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific monitoring or dosage adjustments are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area up to 3 to 4 times daily.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate 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 caution is advised to ensure the well-being of both the mother and the fetus.

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 drug 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 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 contact a Poison Control Center without delay if the substance is ingested. The national Poison Control Center can be reached at 800-222-1222 for guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin. They should be informed to stop using the product and consult a doctor if they experience excessive irritation. Additionally, if the condition worsens or symptoms persist for more than 7 days, patients should be advised to seek medical advice.

Patients should also be counseled to discontinue use and consult a healthcare professional if symptoms clear up and then recur within a few days. It is important to inform patients that while using the product, they should avoid tightly bandaging the area.

Storage and Handling

The product is supplied in a tube format. It is essential to store the product at a temperature range of 15 to 30°C (59 to 86°F) to maintain its efficacy. Healthcare professionals should ensure that the seal on the tube is intact; the product must not be used if the seal is punctured or missing. Proper handling and storage conditions are crucial to ensure the product's quality and safety.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children; in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 800-222-1222.

Drug Information (PDF)

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

View product document (PDF)