Premieres Pain

Description

NDC# 32472-102-01. PREMIER'S PAIN SPRAY™ is formulated for the temporary relief of minor aches and pains associated with conditions such as arthritis, sore muscles, backache, sprains, stiff joints, and muscle cramps. The product contains natural menthol and is presented in a 1 fluid oz. (29.5 ml) dosage form. This herbal formula is designed to provide targeted relief for various musculoskeletal discomforts.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for the management of arthritis, sore muscles, backache, sprains, stiff joints, and muscle cramps.

There are no known 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 enhanced relief, application is recommended following a warm shower or bath.

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

Contraindications

Application is contraindicated on open wounds or damaged skin due to the risk of exacerbating the injury and potential for infection. Additionally, do not apply tightly bandaged, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from open flames and other sources of ignition.

It is imperative to keep this product out of the reach of children. 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. The product must not be applied to open wounds or damaged skin, and it is advised not to bandage the area tightly after application.

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 resolve and then recur within a few days, the use of this product should be discontinued, and medical consultation is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only and is flammable; therefore, it should be kept away from flames.

In clinical practice, excessive skin irritation has been reported among some participants. Individuals with a known sensitivity to salicylates, including aspirin, should consult a healthcare professional prior to use. If patients experience worsening of their condition, persistent symptoms lasting more than 7 days, or if symptoms resolve and then recur within a few days, it is advised to discontinue use and seek medical advice.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the medication 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 information available regarding the use of PREMIERES PAIN menthol spray during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this medication during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised due to the possibility of infant risk.

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 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance should be sought, or the local poison control center should be contacted without delay.

Healthcare professionals are advised to monitor for potential symptoms associated with overdosage, although specific symptoms are not detailed in the provided information. Prompt recognition and management of any adverse effects are crucial in mitigating risks associated with overdosage.

Management procedures may include supportive care and symptomatic treatment as necessary, depending on the clinical presentation of the patient. It is essential for healthcare providers to remain vigilant and act swiftly in response to any reported cases of overdosage.

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

Patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, they should seek medical assistance or contact a poison center immediately.

It is important to instruct patients to avoid contact with their eyes while using this product. They should also be cautioned against applying it to open wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should not bandage the area tightly after application.

Patients should be encouraged to consult a healthcare provider if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. They 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 available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically for both adults and children aged 2 years and older. Patients should shake the product well before use and apply it to the affected area no more than 3 to 4 times daily. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)