Cold Therapy Pain Relief

Description

The drug is formulated as a tablet. Its chemical name is insert chemical name here. The tablet contains the following inactive ingredients: insert inactive ingredients here. The physical characteristics of the tablet are insert physical characteristics here.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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 spray to the affected area, not exceeding four applications per day. For children under 12 years of age, it is recommended to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

Use is contraindicated in the following situations:

The product should be kept out of reach of children to prevent accidental ingestion. 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 flame. When applying this product, it is crucial to avoid contact with the eyes and mucous membranes. Additionally, it should not be applied to wounds, damaged skin, or irritated skin. Bandaging the area after application is not recommended. Users are advised to wash their hands thoroughly with cool water after use and to refrain from using this product in conjunction with heating pads or devices.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur, it is imperative to stop use and consult a healthcare professional.

General precautions include keeping the product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

If accidental ingestion occurs, obtaining emergency medical help or contacting a Poison Control Center is essential.

Side Effects

Patients should be aware that the product is for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame.

When using this product, patients are advised to avoid contact with the eyes or mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin, and should not be bandaged. Patients should wash their hands with cool water after use and refrain from using the product in conjunction with heating pads or devices.

Patients are instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as this may lead to adverse effects. It is essential to avoid concurrent use to ensure patient safety and efficacy of the treatment.

Regarding laboratory test interactions, there are no specific interactions identified. Therefore, routine laboratory tests can be performed without concern for interference from this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Therapy Pain Relief (menthol 10.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use the spray on the affected area up to four times daily. For children under 12 years of age, it is advised to consult a physician prior to use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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 specific information regarding the use of COLD THERAPY PAIN RELIEF WALGREENS - menthol 10.5% spray during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential. Given the lack of data on potential fetal impacts, it is advisable to consider the risks and benefits before use in this population.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 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 the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations to ensure appropriate care is administered.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in configurations that ensure safe handling and storage. It is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

Due to its flammable nature, the product should not be used while smoking or in proximity to heat or open flames. Users are advised to wash their hands with cool water after handling the product to maintain hygiene and safety.

Additional Clinical Information

The medication is administered topically, with a recommended frequency of application not exceeding four times daily for adults and children aged 12 years and older. For children under 12 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 experiences.

Drug Information (PDF)

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

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