Relieve Your Pain

Description

The product is identified by NDC 72683-005-01 and is a non-toxic, paraben-free pain relief cream formulated by Asutra. It contains 10% menthol, which contributes to its analgesic properties. Additionally, the cream is enriched with moisturizing magnesium and Arnica Montana, enhancing its skin-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 application frequency 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 should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage the area or use it 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. Healthcare professionals must advise patients to avoid contact with the eyes and mucous membranes during application. It is imperative that the product is not applied to wounds or damaged skin. Additionally, patients should be instructed not to bandage the area or use it 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 provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up 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.

General precautions must be taken into account. Pregnant or breastfeeding individuals should consult a healthcare professional prior to using this product to ensure safety for both mother and child.

Finally, it is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only and should be used strictly as directed. Contact with the eyes and mucous membranes should be avoided, and the product must not be applied to wounds or damaged skin. Additionally, patients should refrain from bandaging the area or using the product 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

The use of this medication is contraindicated with the application of bandages or the use of heating pads, as well as with other topical formulations such as ointments, creams, sprays, or liniments. These combinations may alter the intended effects of the medication or increase the risk of adverse 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 necessary. However, healthcare professionals should remain vigilant for any unexpected effects when this medication is used in conjunction with other treatments.

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 important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 drug 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, 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 substance is accidentally ingested.

Prompt intervention is crucial in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address any adverse effects that may arise.

Management procedures should include a thorough evaluation of the patient's condition, monitoring vital signs, and providing supportive care as necessary. It is essential to follow established protocols for the specific substance involved to ensure optimal patient outcomes.

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

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

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, they should seek medical help or contact the Poison Control Center immediately.

Patients should be instructed to stop using the product and consult their healthcare provider 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 avoid contact with their eyes and mucous membranes. They should not apply the product to wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area or using the product in conjunction with heating pads, other ointments, creams, sprays, or liniments.

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 application to the affected area recommended no more than 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 Relieve Your Pain, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)