Budpak Muscle Rub

Description

The product is identified by SPL code 34089-3 and is classified as a topical analgesic. It contains menthol and methyl salicylate as active ingredients. The formulation is presented as a clear, colorless to pale yellow gel. Inactive ingredients include carbomer, ethanol, glycerin, propylene glycol, purified water, and triethanolamine.

Uses and Indications

This drug is indicated for the soothing relief of minor arthritis pain, as well as discomfort associated with aching muscles, joints, and backaches.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The application should be followed by gentle massage until the gel is fully absorbed and disappears from the skin.

For children under 12 years of age, the use of this product is not recommended. Consultation with a healthcare professional is advised prior to use in this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to keep it out of reach of children to prevent accidental poisoning. Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes, as this may lead to irritation.

In the event of excessive skin irritation, the use of this product should be discontinued immediately. It is also crucial to avoid tightly bandaging the area of application, applying it to wounds, broken or irritated skin, or using it in conjunction with a heating pad, as these practices may exacerbate adverse effects.

Patients should be instructed to seek medical attention if the condition worsens, if symptoms persist for more than 10 days, or if symptoms clear up only to recur within a few days. Additionally, if any skin redness or irritation develops, the product should be discontinued, and a healthcare provider should be consulted.

Special caution is warranted for children under 12 years of age, particularly regarding arthritis-like conditions. In such cases, it is essential to consult a doctor before use.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals are encouraged to monitor patients closely for any adverse reactions and to provide guidance on the appropriate use of this product to ensure safety and efficacy.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should be used strictly as directed. It is crucial to keep the product out of reach of children to prevent accidental poisoning.

Contact with the eyes or mucous membranes should be avoided, as this may lead to irritation. In the event of excessive skin irritation, patients are advised to discontinue use immediately. The product should not be applied tightly bandaged, nor should it be used on wounds, broken or irritated skin, or in conjunction with a heating pad.

If the condition being treated worsens, or if symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. Additionally, the product is not recommended for use in children under 12 years of age for arthritis-like conditions without prior consultation with a doctor.

These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication for arthritis-like conditions without consulting a healthcare professional. It is essential for caregivers to seek medical advice before administering this treatment to children in this age group.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Budpak Muscle Rub (menthol gel) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed before prescribing this product to pregnant individuals.

Lactation

There is no specific information regarding the use of Budpak Muscle Rub in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring of these patients.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 understanding 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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15°C to 30°C (59°F to 86°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its efficacy and safety.

Additional Clinical Information

The product is administered topically, with the recommended application frequency for adults and children aged 12 years and older being 3 to 4 times daily. Patients should apply the gel to the affected area and gently massage until it disappears. For children under 12 years of age, the product should not be used without consulting a doctor.

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

Drug Information (PDF)

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

View product document (PDF)