Pain Relieving Roll-on

Description

Safetec is a topical analgesic formulated for fast-acting muscle relief. This product is presented in a roll-on dosage form, facilitating easy application. Each container holds 3 fluid ounces (88 mL) of the solution, which is enhanced with Tea Tree and Eucalyptus Oils, known for their soothing properties. The reorder number for this product is 58003.

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 aged 2 years and older, the recommended dosage is to shake the product well before use and apply it to the affected area. This application should not exceed 3 to 4 times daily.

In the case of children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to salicylates, including aspirin, due to the potential for severe allergic reactions.

Application is not recommended on open wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, tight bandaging of the area where the product is applied should be avoided to prevent compromised circulation and potential skin damage.

Warnings and Precautions

This product is intended for external use only and is flammable. It is imperative to avoid contact with the eyes. In the event of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

Application of this product should be avoided on open wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application. Healthcare professionals should be aware that excessive skin irritation may occur; in such cases, or if the patient has a history of allergic reactions to salicylates, including aspirin, consultation with a physician is recommended.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Regular monitoring of the patient's response to treatment is advised to ensure safety and efficacy.

Side Effects

Patients using this product should be aware of several important warnings and adverse reactions associated with its use. This product is for external use only and is flammable. In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately.

Care should be taken to avoid contact with the eyes, and the product should not be applied to open wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application. Patients who experience excessive skin irritation or have a history of allergic reactions to salicylates, including aspirin, should consult a doctor prior to use.

If the condition being treated worsens, 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 of the product and consult a healthcare professional.

Drug Interactions

Patients with a known hypersensitivity to salicylates, including aspirin, should consult a healthcare professional prior to initiating treatment. This precaution is essential to mitigate the risk of allergic reactions.

No specific interactions with other drugs or laboratory tests have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not indicated at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking well and applying it to the affected area no more than 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor prior to use.

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 specific information regarding the use of Pain Relieving Roll-On (menthol, unspecified form gel) during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential. Due to the lack of data on potential fetal impacts, it is advisable to consider the risks and benefits before use in this population. No dosage modifications or special precautions during pregnancy are outlined in the prescribing information.

Lactation

There is no specific information available regarding the use of this drug in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is swallowed, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to instruct patients to avoid contact with their eyes to prevent irritation or injury.

Healthcare providers should emphasize that the product should not be applied to open wounds or damaged skin, and patients should be cautioned against tightly bandaging the area where the product is applied.

Patients should be informed to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, they should be advised to 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 within a few days.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)