Clean Remedies Cr Pain Relief

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients such as insert inactive ingredients here.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged two years and older, the recommended application frequency is three to four times daily to the affected area. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

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 tightly, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only; contact with the eyes should be avoided. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician for further evaluation.

In cases of accidental ingestion, immediate consultation with a physician is recommended. The product should not be applied to wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied.

Healthcare professionals should advise patients who are pregnant or breastfeeding to contact their physician prior to using this product to ensure safety and appropriateness of use during these sensitive periods.

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 contact with the eyes should be avoided. If symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

This product should be kept out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Patients should not apply the product to wounds or damaged skin, and it is recommended not to bandage the area tightly after application.

For pregnant or breastfeeding individuals, it is essential to contact a physician prior to use to ensure safety for both the patient and the child.

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 Clean Remedies Cr Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

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, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of data necessitates careful consideration of potential risks and benefits. Regular monitoring of renal function may be advisable in patients with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the individual patient's liver status when prescribing this medication.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

Prompt medical evaluation is essential to assess the severity of the situation and to initiate appropriate management strategies. Symptoms of overdosage may vary depending on the specific substance involved, and healthcare providers should be vigilant in monitoring for any adverse effects that may arise.

Management of overdosage should be guided by clinical judgment and may include supportive care, symptomatic treatment, and specific interventions as deemed necessary by the attending physician. It is crucial to follow established protocols and guidelines for the management of overdosage to ensure patient safety and optimal 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin to prevent potential complications. Additionally, patients should be instructed not to bandage the area tightly after application, as this may lead to adverse effects. Clear communication of these points will help ensure safe and effective use of the product.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)