Protec Roll-on

Description

PRO.TEC ATHLETICS is an all-natural roll-on formulation designed for pain relief. This product provides fast-acting, deep-penetrating relief from various conditions, including muscle strains, joint pain, tendinitis, arthritis, sprained ligaments, and bruises. The product is packaged in a 3 fl. oz. (95 mL) container, making it suitable for convenient application during recovery cold therapy.

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 text.

Contraindications

The product should not be used in the following situations:

• Bandaging or the application of heating pads or devices is contraindicated, as this may alter the intended effects of the product.

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

• Application to open wounds or damaged skin is contraindicated due to the risk of adverse reactions.

• Concurrent use with other ointments, creams, sprays, or liniments is not recommended, 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 unintended systemic exposure.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Healthcare providers should instruct patients to discontinue use and seek medical advice 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 using the product if any redness or irritation develops, as these may indicate an adverse reaction.

In cases of accidental ingestion, it is crucial to obtain emergency medical help promptly. This may involve contacting a Poison Control Center to facilitate timely and effective intervention.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, symptoms persist for more than 7 days, or if there is a recurrence of symptoms after initial improvement. Additionally, if redness is present or irritation develops, it is recommended that patients seek medical advice.

Drug Interactions

The use of this medication is contraindicated with other topical formulations, including ointments, creams, sprays, and liniments. Co-administration may lead to altered efficacy or increased risk of adverse effects due to overlapping ingredients or mechanisms of action.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the product can be applied directly onto the affected area without the need for rubbing, massaging, or bandaging. Application may be repeated as necessary, but it is important not to exceed 4 applications per day.

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 prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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 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, the following management procedures are recommended:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, even in the absence of specific overdosage information.

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 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 their 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 their healthcare provider if they experience any redness or irritation. When using this product, it is crucial to emphasize that patients must use it only as directed. They should be cautioned against bandaging the area or using heating pads or devices in conjunction with the product.

Additionally, patients should be instructed to avoid contact with their eyes and mucous membranes, and to refrain from applying the product to open wounds or damaged skin. It is also important to inform patients not to use this product alongside other ointments, creams, sprays, or liniments. After application, patients should wash their hands thoroughly with cool water to ensure safety and hygiene.

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, it is critical to keep the product away from excessive heat sources and open flames to prevent any hazardous situations. Proper handling and storage conditions are vital for safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Protec Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)