Cold and Hot Paim Relieving

Description

No specific description details related to SPL code 34089-3 are provided in the text.

Uses and Indications

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

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to ensure that if the medicine comes into contact with the hands, they should be washed thoroughly with soap and water to prevent unintended exposure.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging tightly or using it in conjunction with a heating pad, as these practices may lead to adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, as this may result in irritation or injury. The product should not be applied to wounds or any areas of damaged, broken, or irritated skin.

In the event of pain, swelling, or blistering at the site of application, the use of the product should be discontinued immediately, and medical attention should be sought. It is essential to note that over-the-counter topical muscle and joint pain relievers should not induce pain or cause skin damage.

Healthcare professionals should advise patients to stop using the product and consult a physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

This product is flammable; therefore, it should be kept away from fire or flame to prevent any risk of combustion. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using the topical muscle and joint pain reliever may experience various adverse reactions, particularly skin reactions. Serious skin reactions can manifest as pain, swelling, or blistering at the site of application. In such cases, patients are advised to discontinue use immediately and seek medical attention. Other notable skin-related adverse reactions include worsening of the condition, the presence of redness, development of irritation, and persistence of symptoms for more than seven days, or recurrence of symptoms after initial resolution within a few days.

It is important to note that the product is intended for external use only and should be used strictly as directed. Patients should avoid tightly bandaging the area of application or using the product in conjunction with a heating pad. Additionally, contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or any damaged, broken, or irritated skin.

Furthermore, the product is flammable; therefore, patients should keep it away from fire or flame to prevent any hazardous situations.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Hot Paim Relieving (menthol 16.00%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding due to the lack of specific studies on its effects on nursing infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information 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 consider 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 provided data.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that ensures safe handling and storage. It is classified as flammable; therefore, it must be kept away from fire or flame. This product is intended for external use only. In the event that the medicine comes into contact with hands, it is advised to wash the area thoroughly with soap and water.

To ensure safety, the product should be kept out of reach of children. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

Patients should be advised that the product is for external use only and must be applied topically to the affected area, not exceeding 3 to 4 times daily for adults and children over 12 years. Clinicians should instruct patients to use the product only as directed, avoiding tight bandaging or the use of heating pads. It is crucial to prevent contact with eyes and mucous membranes, and the product should not be applied to wounds or damaged skin.

Patients experiencing pain, swelling, or blistering at the application site should discontinue use and seek medical attention immediately. The product should not cause pain or skin damage; however, if the condition worsens, redness occurs, irritation develops, or symptoms persist beyond 7 days or recur shortly after resolution, patients should consult a healthcare provider. Additionally, the product is flammable and should be kept away from fire or flame, out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)