Jack Black Performance Remedy Dragon Ice

Description

The product is identified by the SPL code 34089-3. It is designated as 01b LBL_JB_Dragon Ice.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years or older, the recommended application is to apply the product to the affected areas no more than 3 to 4 times daily. It is advised to gently massage the product into the achy points on the body to ensure effective absorption.

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

After application, hands should be washed thoroughly with cool water to prevent accidental contact with sensitive areas.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event of accidental swallowing, immediate medical assistance should be sought or contact with a poison control center is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with eyes and mucous membranes. The product should not be applied to sensitive areas, including the face or eye region.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued immediately, and a healthcare professional should be consulted.

The product must not be applied to wounds, damaged skin, or any irritated areas. Additionally, it is crucial to avoid tightly bandaging the area where the product is applied, as well as the use of a heating pad in the same area.

This product should be kept out of reach of children. In the case of accidental ingestion, it is essential to seek medical assistance or contact a poison control center without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes or mucous membranes. It is contraindicated for use on sensitive areas, including the face and eye region.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. Additionally, the product should not be applied to wounds, damaged skin, or irritated areas.

Patients should avoid tightly bandaging the area where the product is applied and should not use a heating pad in the same area. These precautions are essential to ensure the safe and effective use of the product.

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 Jack Black Performance Remedy Dragon Ice (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be closely monitored when using this medication. For adults and children aged 2 years and older, the recommended application is to the affected areas no more than 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a doctor prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is necessary.

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 may use this medication as no specific safety concerns regarding pregnancy have been noted. There are no dosage modifications required for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy are included in the prescribing information. Healthcare professionals should continue to monitor the health of both the mother and fetus as part of standard prenatal care.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

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 toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment 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 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 the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help immediately or contact a poison control center for assistance. It is important for patients to understand the urgency of this situation to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the cap is closed tightly to maintain its efficacy. Proper storage conditions are critical to prevent degradation and ensure the product remains safe for use.

Additional Clinical Information

The medication 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, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)