Pain Goodbye Medicated Cream

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with simple backache, arthritis, and strains.

Limitations of Use: There are no known 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 a few drops of the product to the affected area and rub gently. This application should be performed 3 to 4 times daily, depending on the severity of the condition.

For children under the age of 12, the product is not recommended for use. Healthcare professionals should advise caregivers to consult a doctor for appropriate alternatives or guidance.

Contraindications

The product should not be applied to the nose or genital area due to potential irritation. If rashes, redness, or itchiness occur, discontinue use immediately and consult a healthcare professional.

Warnings and Precautions

Use of this product should be strictly in accordance with the provided directions. It is intended for external use only and must be kept away from the eyes, mucous membranes, rashes, wounds, or any damaged skin. The packaging is not child-resistant; therefore, in the event of accidental ingestion, immediate medical attention should be sought.

To ensure safety, this product must be stored out of reach of children. It is contraindicated for application on the nose and genital area. Should any adverse reactions such as rashes, redness, or itchiness occur, the use of the product should be discontinued immediately, and a healthcare professional should be consulted.

Individuals with a known propensity for allergic reactions to this product are advised to seek medical advice prior to use.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the necessity to use the product only as directed and for external use only. It is crucial to avoid contact with the eyes, mucous membranes, rashes, wounds, or damaged skin. The packaging is not child-resistant; therefore, in the event of accidental ingestion, patients should contact a doctor immediately.

Common adverse reactions may include rashes, redness, and itchiness. If any of these reactions occur, patients are advised to discontinue use and consult a doctor. Additionally, individuals who are prone to allergic reactions to the product should seek medical advice prior to use.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Goodbye Medicated Cream (menthol 5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under the age of 12 should not use this medication without consulting a healthcare professional. For adolescents and children aged 12 years and older, the recommended dosage is to apply a few drops to the affected area and rub gently 3 to 4 times daily.

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

There is no information available regarding the use of PAIN GOODBYE MEDICATED CREAM during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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, it is crucial to take immediate action. The packaging of this medication is not child-resistant, which increases the risk of accidental ingestion, particularly in pediatric populations.

Recommended Actions Healthcare professionals should advise patients and caregivers to contact a physician or poison control center immediately if an accidental ingestion occurs. Prompt medical evaluation is essential to assess the situation and determine the appropriate course of action.

Potential Symptoms While specific symptoms of overdosage may vary depending on the substance involved, it is important for healthcare providers to be vigilant for any signs of toxicity or adverse reactions that may arise following an overdose.

Management Procedures Management of an overdosage should be guided by clinical judgment and may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. Healthcare professionals should follow established protocols for the management of overdose cases, ensuring that all interventions are tailored to the individual patient's needs.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed not to apply the product on the nose or genital area. In the event of rashes, redness, or itchiness, patients are encouraged to discontinue use immediately and consult a healthcare professional for further evaluation and guidance.

Additionally, patients with a history of allergic reactions to similar products should be advised to consult their healthcare provider prior to using this product to ensure safety and appropriateness of use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature to maintain its efficacy. Additionally, the product must be protected from light to prevent degradation.

To ensure the integrity of the product, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to avoid any potential safety or efficacy issues.

Additional Clinical Information

The medication is administered topically, with a recommended application of a few drops to the affected area, gently rubbed in 3 to 4 times daily for adults and children aged 12 years and older. For children under the age of 12, it is advised to consult a doctor before 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 Pain Goodbye Medicated Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)