Premieres Pain

Description

Premiere's Pain Spray Roll On is formulated for the temporary relief of minor aches and pains associated with conditions such as minor sports injuries, backaches, sore muscles, sprains, arthritis, and muscle cramps. The product contains natural menthol and is presented in an herbal formula. Each bottle contains a net volume of 3 fluid ounces (88 mL). The National Drug Code (NDC) for this product is 32472-102-03.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. It is suitable for the management of minor sports injuries, backaches, sore muscles, sprains, arthritis, and muscle cramps.

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 enhanced relief, application is recommended after a warm shower or bath.

For children under 2 years of age, it is advised 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. Additionally, the product should not be applied to open wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Tight bandaging of the area where the product is applied is also contraindicated, as it may increase the risk of skin irritation. If excessive skin irritation occurs, consultation with a healthcare professional is advised.

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 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 doctor 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 should be aware that the product is for external use only and is flammable; it should be kept away from flames. It is crucial to keep the product out of reach of children, as ingestion may necessitate immediate medical assistance or contact with a poison center.

Participants are advised to avoid contact with the eyes and to refrain from applying the product to open wounds or damaged skin. Additionally, it is recommended not to bandage the area tightly after application. In clinical observations, if excessive skin irritation occurs, or if patients have a history of allergic reactions to salicylates, including aspirin, they should consult a doctor.

Should the condition worsen, or if symptoms persist for more than 7 days or clear up and recur within a few days, patients are instructed to discontinue use and seek medical advice.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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 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 drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

There is currently no information available regarding the use of PREMIERES PAIN menthol spray during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this product in pregnant patients. Healthcare professionals are advised to exercise caution and consider the absence of data when prescribing this medication to women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed in the context of individual patient circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should be directed to a poison control center for further guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, it is essential to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and improve patient outcomes.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of the 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a poison center immediately.

Patients should be instructed to avoid contact with the eyes and to refrain from applying the product to open wounds or damaged skin. It is important to inform patients not to bandage the area tightly after application.

Healthcare providers should counsel patients to consult a doctor if they experience excessive skin irritation or if they have a history of allergic reactions to salicylates, including aspirin. Patients should be made aware 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

The product is administered topically for adults and children aged 2 years and older. Patients are advised to shake the product well before application and to apply it to the affected area no more than 3-4 times daily. For enhanced relief, it is recommended to use the product after a warm shower or bath.

No additional information is 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)