Activon Ultra Strength Arthritis

Description

ACTIVON® ARTHRITIS is a topical analgesic formulated for ultra strength pain relief specifically targeting arthritis, joint, and muscle pain. The product is packaged in a 57 g canister carton, with a net weight of 2 ounces (57 g). It is identified by the National Drug Code (NDC) 51068-507-01. An additional feature of this formulation is its no-mess application, enhancing user convenience.

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. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

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. Additionally, the product is contraindicated in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

The product should not be used otherwise than as directed. It is also contraindicated for use with heating pads, as this may increase the risk of adverse effects. Contact with eyes, wounds, mucous membranes, or broken or irritated skin should be avoided to prevent irritation or injury. Sharing this product with others is not advised, and it should not be bandaged tightly to ensure proper circulation.

Warnings and Precautions

For external use only. This product should not be used otherwise than as directed. It is contraindicated in individuals with known allergies to any ingredient in this formulation. Additionally, the product 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 apply tight bandages over the treated area.

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.

Emergency medical assistance should be sought immediately if the product is ingested. It is crucial to keep this product out of the reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be initiated without delay.

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 important not to share the product with others and to refrain from applying tight bandages over the treated area.

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

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Arthritis (menthol, unspecified form). 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 aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the drug insert does not provide any recommendations or considerations for this population. There are no indicated dosage adjustments, safety concerns, or special precautions outlined for geriatric patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the absence of specific data and the potential for variability in response among this demographic. Regular monitoring and assessment of therapeutic outcomes and adverse effects are advisable to ensure the safe and effective use of the medication 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 assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug in human 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 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 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 keep the product out of the reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay for further guidance.

Prompt intervention is crucial in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is essential to follow established protocols for the specific substance to ensure optimal patient outcomes.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product other than as directed. It is important to discuss the potential for allergic reactions; patients should not use the product if they are allergic to any ingredient contained within it. Additionally, patients should be cautioned against using the product on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should emphasize that the product should not be used in conjunction with a heating pad. When using the product, patients must avoid contact with the eyes, wounds, mucous membranes, and broken or irritated skin. It is also crucial to advise patients not to share the product with others and to avoid bandaging the area tightly.

Patients should be instructed to stop using the product 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. Furthermore, they should be advised to discontinue use and seek medical advice if they experience skin redness or excessive irritation.

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 further 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 Arthritis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)