Avedana Cool Hot Ice

Description

No relevant information is available for SPL code 34089-3.

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

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to application. For adults and children aged 2 years and older, the product 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 product may be used in conjunction with ice packs to enhance comfort. Additionally, it can be applied with either wet or dry bandages; however, it is important to wrap the bandage loosely to avoid constriction.

For children under 2 years of age, it is advised to consult a physician before use to ensure safety and appropriateness of treatment.

Contraindications

The product should not be used internally, with heating pads or devices, or on wounds or damaged skin. When using this product, it is important to avoid bandaging tightly and to prevent contact with eyes and mucous membranes.

Warnings and Precautions

For external use only; contact with eyes should be strictly avoided. It is imperative that the product is used solely 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 user should contact a Poison Control Center without delay.

Patients with sensitive skin are advised to consult their healthcare provider prior to use.

Side Effects

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

Additionally, it is recommended that individuals with sensitive skin consult a healthcare professional prior to use to ensure safety and minimize the risk of adverse reactions.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older should have their skin cleaned thoroughly before applying the medication liberally to the affected area. The application may be done no more than 3-4 times daily, and no protective cover is required. 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 potential adverse effects or changes in efficacy, 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 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 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.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored in a controlled environment, maintaining a temperature range between 59°F and 86°F (15°C and 30°C).

To ensure product integrity, the container must remain tightly closed when not in use. It is imperative to avoid exposure to heat sources, open flames, or any conditions that may lead to spillage or improper storage.

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 Avedana Cool Hot Ice, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)