Neilmed Hot and Cold Pain Relief

Description

NeilMed Hot & Cold Pain Relief Spray is a topical formulation designed for pain management. The product is presented in a spray dosage form, facilitating easy application to affected areas. It is formulated to provide both hot and cold sensations, aiding in the relief of pain. The specific composition and inactive ingredients are proprietary, ensuring optimal efficacy and safety for users.

Uses and Indications

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

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for comprehensive treatment of underlying conditions.

Dosage and Administration

The product should be shaken well before use. For adults and children aged 12 years and older, the recommended administration is to spray the product on the affected area, not exceeding 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

Use is contraindicated in patients who have ingested the product. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or flames. Long-term storage above 104°F is not recommended. The container is under pressure; hence, it must not be punctured or incinerated. Additionally, it should not be stored at temperatures exceeding 120°F.

When applying this product, it is crucial to avoid contact with the eyes and mucous membranes. It should not be applied to wounds or damaged skin, and tight bandaging is discouraged. The product must be used strictly as directed.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The product should not be used for longer than one week.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or breastfeeding, it is advisable to consult a healthcare professional prior to use.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is classified as flammable. Therefore, it should not be used while smoking or near heat or flames, and long-term storage above 104°F should be avoided. Additionally, the product should not be punctured or incinerated, as it is under pressure, and storage at temperatures exceeding 120°F is not recommended.

While using this product, patients should take care to avoid contact with the eyes and mucous membranes. It should not be applied to wounds or damaged skin, and tight bandaging is discouraged. Patients are advised to use the product only as directed. If the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. The product should not be used for longer than one week.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Pregnant or breastfeeding individuals should consult a healthcare professional before using this product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Neilmed Hot and Cold Pain Relief (pain relief spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should consult a doctor before use. The product must be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact a Poison Control Center.

For adults and children aged 12 years and older, the recommended dosage is to spray the product on the affected area no more than 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

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; however, prompt recognition and intervention are crucial. The management of overdosage typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

Healthcare providers are encouraged to monitor the patient closely for any adverse effects and to initiate appropriate treatment protocols as necessary.

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 the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that ensures safe handling and storage. It is essential to note that the product is flammable; therefore, it should not be used while smoking or in proximity to heat sources or open flames.

For optimal storage conditions, it is crucial to avoid long-term storage at temperatures exceeding 104°F. Additionally, the product must not be stored at temperatures above 120°F. Care should be taken to prevent puncturing or incinerating the container, as it is under pressure. Proper adherence to these guidelines will help maintain the integrity and safety of the product.

Additional Clinical Information

Patients should be advised that the product is administered topically. For adults and children aged 12 years and older, the spray should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding before using the product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)