Natures Choice Cool Hot Ice

Description

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

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned thoroughly prior to application. The medication should be applied liberally to the affected area no more than 3 to 4 times daily. There is no need for a protective cover after application.

The medication may be used in conjunction with ice packs to enhance its effects. Additionally, it can be applied with either wet or dry bandages; however, it is important to wrap the bandage loosely to avoid restricting circulation.

For children under 2 years of age, it is advised to consult a doctor before use.

Contraindications

The product is contraindicated for internal use, particularly in conjunction with heating pads or devices, and should not be applied to wounds or damaged skin. Tight bandaging is not recommended. Additionally, contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only; contact with eyes should be strictly avoided. It is imperative that this product is used only as directed. Users should refrain from applying tight bandages and must ensure that the product does not come into contact with eyes or mucous membranes.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients with sensitive skin are advised to consult their healthcare provider prior to using this product.

Side Effects

Patients should be advised that the product is for external use only and must be kept away from the eyes to prevent irritation or injury.

Additionally, it is recommended that patients consult a doctor prior to use if they have sensitive skin, as this may increase the risk of adverse reactions.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Natures Choice Cool Hot Ice (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the medication. It is recommended that the skin be cleaned thoroughly before application. The medication should be applied liberally to the affected area no more than 3-4 times daily, and no protective cover is necessary.

For children under 2 years of age, it is advised to consult a doctor prior to use.

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. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 limits the assessment of potential risks associated with the use of the compound in question.

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. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product internally, with heating pads, or on wounds or damaged skin. It is essential to use the product only as directed, avoiding tight bandaging, and to prevent contact with the eyes and mucous membranes.

Additionally, healthcare providers should encourage patients to consult their doctor before using the product if they have sensitive skin. This precaution is important to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a tightly sealed container to ensure integrity and stability. It should be stored at a temperature range of 59°F to 86°F (15°C to 30°C). It is essential to keep the container tightly closed when not in use to prevent contamination. Additionally, the product must not be used, poured, spilled, or stored near heat sources or open flames to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of 3-4 times daily to the affected area. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding before use. It is also important to instruct patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of accidental ingestion.

Drug Information (PDF)

This file contains official product information for Natures Choice Cool Hot Ice, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)