Relieve Your Pain

Description

The product is identified by NDC 72683-005-01 and is formulated as a pain relief cream. It contains 10% menthol, which contributes to its analgesic properties. The cream is non-toxic and paraben-free, ensuring a safer application. Additionally, it includes moisturizing magnesium and Arnica Montana, which may enhance its soothing effects. The net weight of the product is 3.4 oz (96 g).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Contraindications

The product is contraindicated for application on wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be bandaged or used in conjunction with heating pads, other ointments, creams, sprays, or liniments, as this may lead to increased absorption and potential side effects.

Warnings and Precautions

Use of this product should be strictly in accordance with the provided directions, as it is intended for external use only.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be bandaged or used in conjunction with heating pads, other ointments, creams, sprays, or liniments, as this may lead to adverse effects.

Patients should be advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should use this product only as directed and for external use only. It is important to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and patients should refrain from bandaging the area or using it in conjunction with heating pads, other ointments, creams, sprays, or liniments.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then reoccur within a few days, patients are advised to stop use and consult a healthcare professional.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use.

This product should be kept out of reach of children. In cases of accidental ingestion, it is crucial to seek medical assistance or contact the Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Geriatric Use

There is no specific information available 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved and the amount ingested. Therefore, a thorough assessment by a healthcare provider is essential to determine the appropriate course of action.

Management of overdosage may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to address any complications that may arise during the management process.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Serious side effects have been reported voluntarily and through surveillance programs. Healthcare professionals are encouraged to report any serious adverse events to the designated contact number provided.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek medical help or contact the Poison Control Center immediately.

Patients should be instructed to stop using the product and consult their doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

While using this product, patients must be cautioned to avoid contact with their eyes and mucous membranes. They should not apply the product to wounds or damaged skin. Additionally, patients should be informed not to bandage the area or use the product in conjunction with heating pads, other ointments, creams, sprays, or liniments to ensure safe and effective use.

Storage and Handling

The product is supplied in a tamper-evident container to ensure user safety; it should only be used if the safety seal is intact. It is essential to store the product in a cool, dry place, away from direct sunlight. Additionally, it must be kept away from excessive heat or flame to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Patients are also instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)