Tjz Night-Time Topical Pain Relief Balm

Description

TJz balm is a topical pain relief formulation designed for night-time use. This 0.5 oz (14 g) balm provides moisturizing and soothing properties specifically targeting discomfort in the jaw, neck, and behind the ears. The product features a hands-free, massaging tip applicator for ease of use. A portion of the profits from TJz balm will be donated to support TMJ research.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves using the applicator tip to massage the product into the affected area before bedtime. This method ensures optimal absorption and effectiveness during the night.

For children 12 years of age or younger, it is imperative to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated for application on wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be covered with a bandage or subjected to heat, as this may alter its efficacy and safety profile.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates.

It is imperative that the product is used strictly as directed. Patients should be cautioned to avoid contact with the eyes and mucous membranes. Following application, hands should be washed thoroughly with soap and water to prevent unintended exposure. The product should not be applied to wounds or damaged skin, and it is advised not to cover the treated area with a bandage or apply heat, as this may exacerbate adverse effects.

Patients should be instructed to discontinue use and seek medical advice if the condition worsens, if redness or skin irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential for serious allergic reactions, particularly in individuals with a known allergy to aspirin or salicylates. It is advised that such patients consult a healthcare professional prior to use.

Common adverse reactions may include skin irritation or redness, particularly if the product is applied to wounds or damaged skin. Participants in clinical settings have been advised to avoid contact with eyes and mucous membranes to prevent adverse effects. Additionally, the product should not be covered with a bandage or subjected to heat, as this may exacerbate irritation.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if redness or skin irritation occurs, or if symptoms persist for more than seven days or recur shortly after resolution.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional, especially for those with sensitive skin, prior to using the product.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Furthermore, the product is flammable; therefore, it should be kept away from excessive heat or open flames to prevent fire hazards.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use. This precaution is essential to avoid potential allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, it is always advisable for patients to inform their healthcare providers of all medications and supplements they are taking to ensure comprehensive care.

Packaging & NDC

Below are the non-prescription pack sizes of Tjz Night-Time Topical Pain Relief Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering individual patient factors and potential risks.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are pregnant or breastfeeding, particularly if they have sensitive skin. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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

Serious adverse reactions have been reported voluntarily or through surveillance programs. These reports are directed to TJz Balm at PO Box 1778, Boca Raton, FL 33429-1778, USA. The nature and frequency of these reactions are monitored to ensure ongoing safety evaluation of the product.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if they experience redness or skin irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Patients should be reminded to use the product strictly as directed. They should be cautioned to avoid contact with the eyes and mucous membranes during application. After using the product, patients should wash their hands thoroughly with soap and water to prevent unintended exposure.

Additionally, healthcare providers should inform patients not to apply the product to wounds or damaged skin. They should also be advised against covering the treated area with a bandage or applying heat, as this may affect the product's efficacy and safety.

Storage and Handling

The product is supplied in a secure container designed to maintain its integrity. It is essential to store the product in a cool, dry place, ensuring that it is kept away from heat sources. The lid should be closed tightly to prevent contamination and preserve the quality of the product. Proper storage conditions are crucial for maintaining the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Tjz Night-Time Topical Pain Relief Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)