Analgesic

Description

Safetec First Aid Pain Spray is indicated for the temporary relief of minor aches and pains. The product is available in a 4 fl. oz. (118 ml) dosage form. The National Drug Code (NDC) for this formulation is 61010-8200-1.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

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

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:

Patients with a known allergy to salicylates, including aspirin, should avoid use due to the risk of allergic reactions. Application to open wounds or damaged skin is contraindicated to prevent further irritation or complications. Additionally, tight bandaging of the treated area is not recommended. If excessive skin irritation occurs, or if the condition worsens, persists for more than 7 days, or recurs shortly after resolution, discontinue use and consult a healthcare professional.

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.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison center is recommended.

Healthcare professionals should advise patients to avoid contact with the eyes. The product should not be applied to open wounds or damaged skin, and it is crucial to avoid tight bandaging of the area where the product is applied.

Patients should be monitored for excessive skin irritation. If such irritation occurs, or if there is a known history of allergic reactions to salicylates, including aspirin, consultation with a healthcare provider is advised.

In cases where the condition worsens, or 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.

Side Effects

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

In the event of accidental ingestion, it is crucial to keep the product out of reach of children and seek medical assistance or contact a poison center immediately. Users should avoid contact with the eyes and refrain from applying the product to open wounds or damaged skin. Additionally, it is advised not to bandage the area tightly after application.

Patients are encouraged to consult a healthcare professional if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended to discontinue use and consult a doctor.

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 drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not indicated. However, healthcare providers should remain vigilant and consider individual patient factors when assessing potential interactions.

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 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available 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 importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There is no specific information regarding the use of the 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 compound in these areas.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison center immediately.

Patients should be cautioned to avoid contact with their eyes, as this may lead to irritation. It is important to inform them not to apply the product to open wounds or damaged skin, and to avoid tight bandaging of the area where the product is applied.

Healthcare providers should encourage patients to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Additionally, patients should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they 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 assigned 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

For adults and children aged 2 years and older, the product should be shaken well before application to the affected area, with a recommended frequency of no more than 3-4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)