Protec Pain Relief Cold Therapy

Description

PRO-TEC ATHLETICS is an all-natural spray formulated for pain relief, specifically designed for recovery through cold therapy. This product provides fast-acting, deep-penetrating relief from various conditions, including muscle strains, joint pain, tendinitis, arthritis, sprained ligaments, and bruises. Each container holds 4 fluid ounces (126 mL) of the solution, ensuring a sufficient supply for effective treatment.

Uses and Indications

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

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

Dosage and Administration

No dosage and administration information is provided in the insert text. Therefore, healthcare professionals are advised to refer to the relevant prescribing information or clinical guidelines for specific dosing recommendations and administration techniques. It is essential to ensure that any prescribed dosage aligns with the patient's individual needs and clinical condition.

Contraindications

The product is contraindicated in the following situations:

• Bandaging or the use of heating pads or devices is not recommended, as this may alter the product's effectiveness or increase the risk of adverse effects.

• Contact with eyes and mucous membranes should be avoided to prevent irritation or injury.

• Application to open wounds or damaged skin is contraindicated due to the potential for increased absorption and systemic effects.

• Concurrent use with other ointments, creams, sprays, or liniments is not advised, as this may lead to unpredictable interactions or reduced efficacy.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent potential adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. This precaution is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur. Additionally, patients should be advised to stop use if redness or irritation develops, as these may indicate an adverse reaction that requires further evaluation.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, if redness is present or irritation develops, it is advised to stop use and seek medical advice.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is not recommended. The potential for altered efficacy or increased risk of adverse effects necessitates avoiding such combinations.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, no adjustments or special monitoring related to laboratory tests are required.

Packaging & NDC

Below are the non-prescription pack sizes of Protec Pain Relief Cold Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may use the product by spraying it directly onto the affected area without the need for rubbing, massaging, or bandaging. The application may be repeated as necessary, but it should not exceed 4 times daily.

For pediatric patients under 2 years of age, consultation with a physician is advised prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 medication in 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 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 use of the compound in these contexts.

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 in the event of accidental ingestion of the product. It is important for patients to understand that they should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Patients should also be informed to stop using the product and consult a healthcare professional if they experience any redness or irritation. When using this product, it is crucial to emphasize the following instructions:

• Patients should use the product only as directed and avoid bandaging or using any heating pads or devices in conjunction with the product.

• They should take care to avoid contact with the eyes and mucous membranes, and not to apply the product to open wounds or damaged skin.

• It is also important to advise patients against using the product alongside other ointments, creams, sprays, or liniments.

• After application, patients should wash their hands thoroughly with cool water to prevent unintended exposure.

Storage and Handling

The product is supplied in a secure container that must be stored in a cool, dry place. It is essential to ensure that the lid or cap is closed tightly to maintain the integrity of the product.

Due to its flammable nature, the product should be kept away from excessive heat sources and open flames to prevent any potential hazards. Proper handling and storage conditions are crucial for safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)