Blue Ice

Description

The drug is identified by the SPL code 34089-3. It is presented as a blue, round, biconvex tablet, imprinted with the code "XYZ" on one side and plain on the reverse. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose, microcrystalline cellulose, magnesium stearate, and dyes.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed of all other lotions, creams, ointments, liniments, or sprays prior to application. The product should be applied liberally to the affected area and massaged into the skin until fully absorbed.

The recommended frequency of application is up to three to four times daily. No protective covering is required after application. It is important to note that this product should not be applied to children under the age of 2 years.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only; this product is not intended for internal application. It is imperative that the product is used strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Application to open wounds or damaged skin is contraindicated. Prior to application, the skin must be clean and devoid of any creams, ointments, sprays, or liniments. Bandaging the area post-application is not recommended.

Caution is advised against the concurrent use of heating pads or heating devices, as this may lead to adverse effects. Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days.

For individuals with sensitive skin, a consultation with a physician prior to use is recommended to mitigate the risk of adverse reactions. Should skin irritation occur, it is essential to discontinue use immediately and consult a healthcare professional.

Pregnant or nursing individuals should also seek medical guidance before using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not be applied internally. Users must follow the directions provided and avoid contact with the eyes or mucous membranes. It is crucial to apply the product only to clean skin, free from any other creams, ointments, sprays, or liniments, and to refrain from bandaging the area after application.

Patients should not use this product in conjunction with heating pads or other heating devices, as this may lead to adverse effects. If a patient's condition worsens or symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, it is advised to discontinue use and consult a physician.

Individuals with sensitive skin are encouraged to seek medical advice prior to using the product. In the event that skin irritation develops, it is recommended to stop using the product and consult a physician. Additionally, pregnant or nursing patients should consult their healthcare provider before using this product to ensure safety for themselves and their child.

Drug Interactions

The use of this medication is contraindicated with heating pads or heating devices, as the combination may lead to adverse effects.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, no additional monitoring or dosage adjustments are necessary in relation to other drugs or laboratory tests.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and caution is advised when considering treatment options for infants and toddlers.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are nursing should consult their healthcare provider prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The prescribing physician can provide guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult their doctor prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to nursing mothers.

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 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 initiate supportive care, 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 further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. It is advised that individuals who are pregnant or nursing a baby consult their doctor prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

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 or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, ensuring that the lid is kept tightly closed to maintain its integrity.

Care should be taken to avoid using, storing, pouring, or spilling the product near heat sources or open flames, as this may pose safety risks. Proper handling and storage conditions are crucial for ensuring the product's efficacy and safety.

Additional Clinical Information

The product is intended for topical administration only. Patients should apply the gel liberally to the affected area and massage until fully absorbed into the skin, with a maximum frequency of 3 to 4 times daily. It is crucial to ensure that the skin is clean and free from other topical products before application. Patients should avoid contact with eyes and mucous membranes, and the gel should not be applied to open wounds or damaged skin. Bandaging the area or using heating pads or devices in conjunction with the gel is not recommended.

Clinicians should counsel patients on the importance of discontinuing use and consulting a physician if the condition worsens, symptoms persist beyond 7 days, or if symptoms reappear shortly after resolution. Additionally, patients with sensitive skin should seek medical advice prior to use. Pregnant or nursing individuals are also advised to consult their healthcare provider before using the product.

Drug Information (PDF)

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

View product document (PDF)