Coralite Cold and Hot

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. It should be applied no more than three times daily. The patch should not be worn for more than 8 hours at a time. For children under 12 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

No dosage and administration information is available in the provided text. Please provide the necessary details to facilitate the creation of this section.

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the risk of exacerbating the injury or causing infection. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and potential skin damage. Furthermore, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is not intended for application on wounds or damaged skin. It is contraindicated to use this product in conjunction with a heating pad. Additionally, it should not be administered to children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve and then reappear within a few days; or if excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

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

Before using this product, patients should ask a doctor if they have redness over the affected area, as this may indicate a more serious condition that requires professional evaluation.

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 Coralite Cold and Hot (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents aged 12 years and older, the medication should not be applied for more than 8 hours at a time and should be used on the affected area no more than three times daily.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting requirements.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use this product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Patients should be counseled to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to seek medical advice if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with eyes and mucous membranes, and should not bandage the area tightly. Patients should also be informed to discontinue use at least 1 hour before taking a bath or shower, and to refrain from using the product immediately after bathing.

Lastly, patients should be encouraged to consult a doctor before use if there is any redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should not be worn for more than 8 hours and may be applied to the affected area no more than three times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)