Premieres Pain

Description

Premiere's Pain Spray™ is formulated for the temporary relief of minor aches and pains associated with conditions such as arthritis, backache, stiff joints, sore muscles, sprains, and muscle cramps. Each bottle contains 4 fluid ounces (118 ml) of a natural menthol and herbal formula. The product is identified by NDC# 32472-102-04.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it provides relief for conditions such as arthritis, backache, stiff joints, sore muscles, sprains, 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 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 or causing infection. Additionally, do not apply tightly bandaged dressings, 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 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. 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.

Participants are advised to avoid contact with the eyes and not to apply the product to open wounds or damaged skin. It is also recommended not to bandage the area tightly after application.

In clinical use, 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, discontinuation of the product and consultation with a healthcare professional is advised.

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 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.

Caution should be exercised to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately or contact a poison center.

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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for use in pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from 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 question.

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. 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. Additionally, patients should be informed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

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

For patients aged 2 years and older, the recommended administration involves shaking the product well before applying it to the affected area. The application should not exceed 3 to 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 Premieres Pain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)