Analgesic

Description

NDC 61010-XXXX-X, Safetec Pain Relief Spray is a medicated formulation designed for fast-acting relief of minor aches and pains. This product is presented in a dosage form of a spray, with a volume of 2 fluid ounces (59.1 ml). It is intended for temporary relief of discomfort associated with various minor ailments.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. It is specifically designed to provide symptomatic relief for individuals experiencing such discomfort.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug. Therefore, it may be considered safe for use in populations where these concerns are relevant. However, healthcare professionals should always evaluate the individual patient's circumstances before prescribing.

Dosage and Administration

For adults and children aged 2 years and older, the product should be shaken well before use. It is to be applied to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Application to open wounds or damaged skin is prohibited due to the potential for adverse effects and impaired healing. Additionally, tight bandaging is contraindicated as it may lead to compromised circulation and increased risk of tissue damage.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from open flames and other sources of ignition.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a poison control center without delay. Care should be taken to avoid contact with the eyes, as this may lead to irritation or injury.

Application of this product is contraindicated on open wounds or damaged skin. Additionally, it is advised not to apply a tight bandage over the treated area to prevent complications.

Healthcare professionals should advise patients to consult a physician if excessive skin irritation occurs or if there is a known history of allergic reactions to salicylates, including aspirin. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and medical advice should be sought.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from flames.

In clinical practice, patients are advised to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Should the condition worsen, or if symptoms persist for more than 7 days or clear up and recur within a few days, it is recommended that patients discontinue use and seek medical advice.

Drug Interactions

Patients with a known hypersensitivity to salicylates, including aspirin, should consult a healthcare professional prior to initiating treatment. This precaution is essential to mitigate the risk of allergic reactions.

No specific interactions with other drugs or laboratory tests have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not indicated at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking well and applying it to the affected area no more than 3-4 times daily. For infants and children under 2 years of age, it is advised to consult a doctor prior to use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There is no specific information available regarding the use of the analgesic menthol spray in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text 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, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help or contact a poison control center without delay.

Healthcare professionals should be aware that exposure to the substance may lead to various symptoms, although specific symptoms are not detailed in the provided information. Therefore, monitoring the patient for any adverse reactions is essential.

Additionally, it is important to avoid contact with the eyes, as this may exacerbate the situation or lead to further complications. Proper precautions should be taken to prevent such exposure during management and treatment.

In summary, prompt action and careful monitoring are key components in the management of overdosage cases involving this substance.

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

Patients should be advised to seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to avoid contact with the eyes to prevent irritation.

Healthcare providers should instruct patients not to apply the product to open wounds or damaged skin and to avoid tight bandaging of the area where the product is applied.

Patients should be counseled to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use of the product and seek medical advice.

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

View product document (PDF)