Coralite Blue Ice

Description

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

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It is recommended that the affected area be cleaned prior to application. The product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

The use of this product is contraindicated in the following situations:

• Co-administration with other topical pain relievers is not recommended due to the potential for increased irritation or adverse effects.

• Application in conjunction with heating pads or heating devices is contraindicated, as this may enhance the risk of skin burns or irritation.

• The product should not be applied in or near the eyes to prevent serious ocular irritation or injury.

• Application to wounds or damaged skin is contraindicated due to the risk of exacerbating the injury or causing infection.

• Tight bandaging of the area where the product is applied is not advised, as this may lead to increased local irritation or adverse reactions.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed to ensure safe use. This product should not be used concurrently with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of heating pads or other heating devices in conjunction with this product is contraindicated, as it may exacerbate irritation or discomfort.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if any redness or irritation develops at the application site, medical advice should be sought promptly.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if redness or irritation develops, medical advice should be sought.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is advised to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Healthcare professionals should monitor patients for any signs of adverse reactions when considering the use of this medication in conjunction with other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be monitored closely, as the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is essential to consult a physician before use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the use of activated charcoal if the ingestion occurred within a timeframe that warrants its use.

Healthcare providers should also be prepared to manage any emergent symptoms that may develop, although specific symptoms related to overdosage are not outlined in the current documentation. Continuous assessment and supportive care remain paramount in managing any potential complications arising from overdosage.

For further guidance, healthcare professionals are encouraged to consult local poison control centers or relevant medical toxicology resources.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product should not be used in conjunction with other topical pain relievers, as this may increase the risk of adverse effects.

Patients should be cautioned against using the product with heating pads or any heating devices, as this could lead to increased irritation or burns. They should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, patients should be made aware that they need to stop using the product and seek medical advice if they experience any redness or irritation. It is crucial to instruct patients to avoid applying the product in or near the eyes, on wounds, or on damaged skin. Furthermore, patients should be advised not to bandage the area tightly after application to prevent complications.

Storage and Handling

The product is supplied in a container that must be stored in a cool place. It is essential to keep the lid tightly closed to maintain the integrity of the product. Additionally, the product should not be used, poured, spilled, or stored near heat sources or open flames to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)