Activon Ultra Strength

Description

NEW STRONGEST ACTIV ON® JOINT & MUSCLE is a topical analgesic formulated for ultra-strength relief of joint and muscle pain, including backache. This product is designed for effective pain management while ensuring a no-mess application. The net weight of the formulation is 2 ounces (57 grams), and it is identified by the National Drug Code (NDC) 51068-503-01.

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, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the affected area is dry before application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to any ingredient in this product should not use it due to the risk of allergic reactions.

The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Additionally, the use of this product in conjunction with a heating pad is contraindicated, as this may lead to increased risk of adverse effects.

It is essential to use this product only as directed; any deviation from the recommended usage is contraindicated.

Warnings and Precautions

For external use only. This product should not be used otherwise than as directed. It is contraindicated in individuals who are allergic to any ingredient in this formulation. Additionally, it should not be applied to children under 12 years of age who present with arthritis-like conditions, nor should it be used in conjunction with a heating pad.

When utilizing this product, it is imperative to avoid contact with the eyes, wounds, mucous membranes, and any broken or irritated skin. The product is intended for individual use and should not be shared with others. Furthermore, it is advised not to bandage the area tightly after application.

Healthcare professionals 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 within a few days. Patients should also be advised to stop use if skin redness or excessive irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated in individuals who are allergic to any ingredient in the formulation, as well as in children under 12 years of age with arthritis-like conditions. The product should not be used in conjunction with a heating pad.

While using this product, patients are advised to avoid contact with the eyes, wounds, mucous membranes, and broken or irritated skin. It is also recommended that the product not be shared with others and that it should not be bandaged tightly.

Patients should discontinue use 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, if skin redness or excessive irritation develops, medical advice should be sought.

For pregnant or breastfeeding individuals, it is important to consult a healthcare professional before use. The product should be kept out of the reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug 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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to use the product only as directed and to refrain from using it if they have a known allergy to any of its ingredients. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should caution patients against using the product in conjunction with a heating pad, as this may lead to adverse effects. Patients 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 resolve and then recur within a few days.

Additionally, patients should be informed to stop using the product and seek medical advice if they experience skin redness or excessive irritation. While using the product, patients should avoid contact with the eyes, wounds, mucous membranes, and any broken or irritated skin. It is also essential to remind patients not to share the product with others and to avoid tightly bandaging the area where the product is applied.

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 controlled environment, maintaining a temperature range between 15° and 30° C (59° and 86° F). Care should be taken to keep the product away from heat sources to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Activon Ultra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)