Activice

Description

The product identified by SPL Code 34089-3 does not have specific description details provided in the available data. Further information regarding its chemical composition, molecular weight, dosage form, or appearance is not available.

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 over 12 years of age, the recommended administration involves spraying the product directly onto the affected area. It is important to note that there is no requirement to rub, massage, or bandage the area following application. If necessary, the application may be repeated; however, it should not exceed four times within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is contraindicated, as this may lead to adverse effects. Additionally, the application of the product to wounds or damaged skin is prohibited due to the potential for irritation or other complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. The product is flammable; therefore, it should be kept away from fire or flame to mitigate the risk of combustion. Additionally, the contents are under pressure; hence, puncturing or incinerating the container is strictly prohibited.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that the product is for external use only, and contact with the eyes should be avoided. The product is flammable; therefore, it should be kept away from fire or flame. Additionally, patients are advised not to puncture or incinerate the container, as it is under pressure.

When using this product, it is crucial to adhere to the directions provided. Patients should avoid bandaging tightly or using the product in conjunction with a heating pad. The application of the product to wounds or damaged skin is not recommended.

Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or excessive skin irritation also warrants cessation of use and medical advice.

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

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

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. Additionally, they should seek medical advice if they notice any redness or experience excessive irritation of the skin.

When using this product, it is essential for patients to use it only as directed. They should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. Furthermore, patients should not apply the product to wounds or damaged skin to avoid potential complications.

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

View product document (PDF)