Tidl Pain Relief Cryo Therapy Unscented Formula Spray.

Description

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

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate dosage and administration tailored to the child's specific needs.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used while smoking or in proximity to heat or open flame due to the risk of fire.

Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Application to wounds, damaged skin, or irritated skin is contraindicated as it may exacerbate the condition. Additionally, the product should not be bandaged or used in conjunction with heating pads or devices, as this may lead to adverse effects. When applying the product, it is essential to spray it away from the nose, eyes, and mouth to minimize the risk of exposure to sensitive areas.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

General precautions must be observed when using this product. Users should ensure that the child safety spray lock is turned to the off position when the product is not in use to prevent accidental exposure. Additionally, caution is advised while smoking or when in proximity to heat sources or open flames, as these conditions may pose a risk.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. These steps are crucial for ensuring patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. It is advised that patients consult a doctor under the same circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Tidl Pain Relief Cryo Therapy Unscented Formula Spray. (pain relief cryo therapy unscented formula spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of TIDL Pain Relief Cryo Therapy Unscented Formula Spray during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits before recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments due to reduced renal function. It is essential to monitor renal function tests regularly in individuals with known kidney problems. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 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 the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to instruct patients to ensure that the child safety spray lock is turned to the off position when the product is not in use to prevent accidental exposure.

Patients should be cautioned against using the product while smoking or in proximity to heat sources or open flames, as this may pose safety risks. They should be informed that if their condition worsens, or if symptoms persist for more than seven days, or if symptoms clear up and then reoccur within a few days, they should consult their healthcare provider.

Healthcare providers should emphasize the importance of avoiding contact with the eyes or mucous membranes, and instruct patients not to apply the product to wounds, damaged skin, or irritated skin. Additionally, patients should be advised not to bandage the area after application.

It is essential to remind patients to wash their hands thoroughly with cool water after using the product to prevent unintended exposure. They should also be informed not to use the product in conjunction with heating pads or devices, and to spray the product away from the nose, eyes, and mouth to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity.

To maintain safety, the product must be kept out of reach of children. Additionally, when not in use, it is crucial to turn the child safety spray lock to the off position to prevent accidental discharge. Proper adherence to these storage and handling guidelines will help ensure the product's efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended that a physician be consulted regarding the appropriate use and administration of the product. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Tidl Pain Relief Cryo Therapy Unscented Formula Spray., including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)