Feel Good Lab Natural Pain Cream

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of the muscles and joints associated with conditions such as arthritis, simple backache, sprains, bruises, and strains.

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it should not be used with tight bandaging, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

External use only is mandated for this product. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. In cases where symptoms persist beyond seven days, it is imperative to discontinue use and consult a physician for further evaluation and management.

For individuals who are pregnant or breastfeeding, it is essential to contact a physician prior to use to ensure safety for both the patient and the child.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to consult a physician if they experience any adverse effects or if symptoms do not resolve as expected.

No specific laboratory tests are recommended for monitoring the use of this product. However, ongoing assessment of the patient's condition is advised to ensure appropriate therapeutic outcomes.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. If swallowed, patients should seek medical advice immediately. It is important not to apply the product to wounds or damaged skin, and bandaging should not be done tightly.

For pregnant or breastfeeding individuals, it is recommended to contact a physician prior to use to ensure safety.

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 Feel Good Lab Natural Pain Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations, as the effects on fetal outcomes and lactation are not fully established. Healthcare professionals are advised to consider individual circumstances and provide appropriate counseling regarding the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. 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 available information.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and guidance.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. It is essential for healthcare providers to monitor the patient closely for any adverse effects that may arise.

Management of overdosage should be conducted in accordance with established medical protocols. This may include supportive care and symptomatic treatment as necessary. Healthcare professionals are advised to refer to local guidelines and resources for specific management recommendations tailored to the situation at hand.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly after application, as this could interfere with the product's effectiveness and safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Feel Good Lab Natural Pain Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)