Arnimax Penetrating Pain Relief Gel

Description

This product is identified by the code 51945-4 and is associated with the package labeling effective as of February 12, 2022. The labeling includes a visual representation, which is available in JPEG format. The product is categorized under the identifier root 09d7163b-7e74-1473-e063-6294a90a81a1, ensuring traceability within the relevant coding systems.

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 mentioned in the available data.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied and gently massaged into the affected area. This application may be performed no more than 3 to 4 times daily. It is essential to wash hands thoroughly with soap and water after each application to prevent unintentional contact with other areas of the body or with other individuals.

For children under 12 years of age, it is recommended to consult a physician prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Contact with eyes and mucous membranes should be avoided to prevent irritation. Application to wounds or broken skin is not recommended due to the potential for adverse reactions. Additionally, tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may exacerbate side effects or lead to complications.

Warnings and Precautions

For external use only. This product should not be used by individuals who are allergic to any of the ingredients listed in the formulation.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Care should be taken to avoid contact with the eyes and mucous membranes. The product must not be applied directly to wounds or broken skin. Additionally, it is advised not to bandage the area tightly or to use a heating pad in conjunction with the application.

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for individuals who are allergic to any of the ingredients listed in the product formulation. When using this product, it is essential to adhere strictly to the directions provided. Patients should avoid contact with the eyes and mucous membranes, and the product should not be applied directly to wounds or broken skin. Additionally, it is advised not to bandage the area tightly or use a heating pad in conjunction with the product.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, persists for more than 7 days, or if the condition clears up and then recurs within a few days. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional prior to use.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Arnimax Penetrating 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 healthcare professional prior to use. For adolescents and children aged 12 and older, the recommended application is to apply and massage a thin layer 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, 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 adverse effects or changes in therapeutic response, 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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health 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 individuals.

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.

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 attention is essential. Healthcare professionals are advised to instruct patients or caregivers to seek medical assistance or contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are crucial. It is important for healthcare providers to be vigilant for any signs of toxicity and to initiate appropriate management procedures based on the clinical presentation.

Management of overdosage should be guided by established protocols, which may include supportive care and symptomatic treatment. Healthcare professionals should ensure that the patient is stabilized and that any necessary interventions are performed promptly to mitigate potential adverse effects.

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 seek medical attention or contact a Poison Control Center immediately if the product is swallowed. It is essential to inform patients not to use the product if they are allergic to any of the ingredients listed.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and then recurs within a few days.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and it is important not to apply the product directly to wounds or broken skin. Additionally, patients should be cautioned against bandaging tightly or using a heating pad in conjunction with the product.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 15° to 25° C (59° to 77° F). It is essential to protect the product from heat and to keep the container tightly closed to maintain its quality and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply and massage a thin layer of the product to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding prior to use. Additionally, patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days.

Drug Information (PDF)

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

View product document (PDF)