Relief Pain Relieving Cream

Description

Relief Pain-Relieving Cream is formulated for topical application to alleviate pain. The product is designed to provide effective relief, with its efficacy confirmed as of October 26, 2023. The cream is packaged in a suitable container for ease of use and storage.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the affected area no more than 3 to 4 times daily. The application should be followed by gentle massage until the product is fully absorbed into the skin.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur after a few days, the use of this product should be discontinued, and a physician should be consulted.

This product should not be applied to wounds or damaged skin. Additionally, it should not be used when bandaged tightly or in conjunction with a heating pad. The application of this product alongside other topical products is also contraindicated.

In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

If the condition worsens or if symptoms persist beyond 7 days, or if there is a recurrence of symptoms after a period of improvement, the use of this product must be stopped, and a healthcare professional should be contacted for further evaluation and guidance.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In clinical use, if the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur after a few days, patients are advised to discontinue use and consult a physician.

The product should not be used on wounds or damaged skin, nor should it be applied when bandaged tightly or in conjunction with a heating pad. Additionally, the use of this product with other topical products is not recommended.

Drug Interactions

The use of this product is contraindicated in conjunction with other topical products, as this may lead to adverse effects or diminished efficacy.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, routine monitoring of laboratory parameters is not required when using this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply a small amount of the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use. 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 contact a Poison Control 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of Relief Pain Relieving Cream (menthol cream) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to women who are pregnant or may become pregnant. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and treatment planning.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. Clinicians should advise patients to gently massage the product until fully absorbed. For children under 2 years of age, consultation with a physician is necessary prior to use.

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 Relief Pain Relieving Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)