Target up and up Pain Relief Menthol Topical Analgesic Roll-on

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "34089" on one side and "3" on the other side, containing 3 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry white, which consists of hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and polysorbate 80.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is not necessary to massage the product into the skin. After application, hands should be washed thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

For children under 2 years of age, the product should not be used without consulting a doctor.

Contraindications

The product is contraindicated for use on wounds or damaged skin, as well as on irritated skin, due to the potential for exacerbating these conditions. Additionally, concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to adverse interactions.

During application, it is essential to avoid contact with the eyes and mucous membranes to prevent irritation. Tight bandaging should be avoided to ensure proper circulation and prevent skin damage. Furthermore, the use of heating pads or devices in conjunction with this product is contraindicated, as it may increase the risk of skin irritation or burns.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

General precautions should be observed to ensure safe use. The product should not be applied to wounds or damaged skin, nor should it be used on irritated skin. Additionally, it is advised not to combine this product with other ointments, creams, sprays, or liniments, as such combinations may lead to adverse effects.

Users are instructed to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, individuals with sensitive skin should seek medical advice before using the product to avoid potential adverse reactions.

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 Target up and up Pain Relief Menthol Topical Analgesic Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

It is important to keep the medication 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.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on managing overdosage cases. It is crucial to document the incident thoroughly and report any adverse effects to the appropriate regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of careful dosing and monitoring during treatment.

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 if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, as well as to avoid using it on irritated skin.

Patients should be informed that the product should not be used in conjunction with other ointments, creams, sprays, or liniments. They should be counseled to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using the product, patients must be cautioned to avoid contact with the eyes and mucous membranes. Additionally, they should be advised against tightly bandaging the area of application and using the product in combination with heating pads or devices.

Finally, healthcare providers should recommend that patients consult a doctor prior to use if they have sensitive skin.

Storage and Handling

The product is supplied in a package configuration that includes specific NDC numbers. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial for ensuring the product remains within its specified quality parameters.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. It is not necessary to massage the area after application, and patients should wash their hands with cool water following use. For children under 2 years of age, the product should not be used without consulting a doctor.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Target up and up Pain Relief Menthol Topical Analgesic Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)