Theralast Maximum Strength Pain Relief Gel

Description

The product is presented in a packaging format that includes a principal display panel. The effective date of the packaging is November 15, 2020. An image of the packaging is available, identified as "theralast revised2," and is formatted as a JPEG file. The product's unique identifier is linked to the code 51945-4, which is part of the code system 2.16.840.1.113883.6.1.

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the recommended application is to the affected area not more than four times daily. It is advised that children under 12 years of age consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated for use in the following situations:

Use is not recommended on large areas of the body due to the potential for systemic absorption and adverse effects. The product should not be used concurrently with other ointments, creams, sprays, or liniments, as this may lead to increased irritation or reduced efficacy. Additionally, the application of a heating pad is contraindicated, as it may enhance absorption and increase the risk of skin irritation.

Contact with eyes or mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or delay healing. Bandaging the area after application is also contraindicated, as it may trap heat and moisture, leading to increased irritation.

If the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, discontinuation of use is advised, and a healthcare professional should be consulted. Excessive skin irritation warrants immediate cessation of use and consultation with a physician.

This product should be kept out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only and should not be applied to large areas of the body. It is contraindicated for use in conjunction with other ointments, creams, sprays, or liniments, and should not be used with a heating pad.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or experience redness over the affected area. During application, it is crucial to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be bandaged after application. Following use, patients should wash their hands thoroughly to prevent unintended contact with other areas of the body.

Patients are instructed to discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical consultation is recommended.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Side Effects

Patients should discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using the product, patients are advised to consult a healthcare provider if they have sensitive skin or experience redness over the affected area.

It is important to note that the product is intended for external use only.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads in conjunction with this medication is also not recommended, as it may lead to increased absorption and potential adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Theralast Maximum Strength Pain Relief Gel (menthol). 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 application is to the affected area no more than four times daily.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding 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 associated with the use of this medication during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved; therefore, a thorough assessment by a healthcare provider is essential.

Management of overdosage should be guided by the clinical presentation and may include supportive care and symptomatic treatment as necessary. Continuous monitoring 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 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 accidentally ingested. It is important to instruct patients not to apply the product to large areas of the body and to avoid using it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should be informed not to use the product with a heating pad.

Patients should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients must be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they bandage the area after application. It is also essential to remind patients to wash their hands thoroughly after using the product.

Finally, healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin or notice redness over the affected area.

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 in a cool, dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children over 12 years. For children under 12 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Theralast Maximum Strength Pain Relief Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)