Budpack

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 backache.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed 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

Use of this product is contraindicated for external use only. It should be utilized strictly as directed. To prevent accidental poisoning, it must be kept out of the reach of children. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Contact with eyes or mucous membranes should be strictly avoided. In the event of excessive skin irritation, the use of this product must be discontinued immediately. It is imperative not to apply the product to wounds, broken or irritated skin, or to use it in conjunction with a heating pad.

Should the condition worsen, or if symptoms persist beyond 10 days, or if there is a recurrence of symptoms after initial improvement within a few days, the use of this product should be stopped. In such cases, consultation with a healthcare professional is advised. This product is contraindicated for use in children under 12 years of age for arthritis-like conditions; a physician should be consulted prior to use in this population.

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

Healthcare professionals should advise patients to discontinue use and seek medical advice if there is any worsening of the condition, persistence of symptoms beyond 10 days, or the development of skin redness or irritation.

Side Effects

Patients using this product should be aware of several important warnings regarding adverse reactions. Contact with the eyes or mucous membranes should be avoided to prevent irritation. In the event of excessive skin irritation, it is 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 a patient's condition worsens, or if symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days, it is recommended to discontinue use and consult a healthcare professional. Additionally, for children under 12 years of age with arthritis-like conditions, consultation with a doctor is necessary before use.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product for arthritis-like conditions and must consult a healthcare professional for guidance. For patients aged 12 years and older, the recommended application is to the affected area not more than 3-4 times daily, with gentle massage until the gel is fully absorbed.

It is crucial to keep this product out of the reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center.

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

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there are no data on the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only and must be used strictly as directed. It is important to emphasize the necessity of keeping the product out of the reach of children to prevent accidental poisoning.

In the event that the product is swallowed, patients should be instructed to seek medical assistance or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and effective use of the product.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature ranging from 15 to 30°C (59 to 86°F) to ensure optimal stability and efficacy.

For tracking purposes, the Lot Number and Expiration Date can be found on the box or the crimp of the tube. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Patients should be advised that the product is for external use only and must be used strictly as directed. It is important to keep the product out of the reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.