Family Wellness Cold and Hot Pain Relief

Description

The product is a topical patch identified by SPL code 34089-3. Each patch contains 3.5 g of menthol as the active ingredient, which is intended to provide a cooling sensation upon application. The formulation includes several inactive ingredients, such as adhesive, polyethylene, non-woven fabric, and other excipients necessary for the formulation.

Uses and Indications

This drug is indicated for the topical treatment of localized pain in adults and children over 12 years of age. The patch should be applied with the sticky side directly to the affected area. Application may be repeated as necessary, but should not exceed four times daily.

For children under 12 years of age, it is advised to consult a physician prior to use.

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

Dosage and Administration

There is currently no dosage and administration information available for the product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in infants.

Due to the potential risk of serious adverse effects, the product should not be used in children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

The product should not be applied with tight bandaging or in conjunction with heating pads, as this may exacerbate adverse reactions. Additionally, contact with eyes and mucous membranes must be avoided to prevent irritation. The application of this product to wounds or damaged skin is also contraindicated, as it may lead to further complications.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children and is not used on infants. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days or clear up and then recur within a few days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Cold and Hot Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. The use of this medication is not recommended for infants. For children aged 12 years or younger, it is advised to consult a doctor before use.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing 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 medication 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 from excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to avoid using it on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. It is also important to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, the sticky side of the patch should be applied to the affected area, with a maximum frequency of four applications per day as needed. For children under 12 years, it is advised to consult a doctor before use.

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

Drug Information (PDF)

This file contains official product information for Family Wellness Cold and Hot Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)