Healthwise Pain Relieving Cream

Description

No description information is available for the specified drug.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, contact with the eyes must be avoided to prevent irritation or injury. It is also advised not to bandage the area tightly, as this may compromise circulation and lead to further complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin to prevent adverse effects.

When utilizing this product, healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. Additionally, it is important to instruct patients not to apply tight bandages over the treated area, as this could exacerbate potential side effects or hinder the product's effectiveness.

Patients should be closely monitored, and they must be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure patient safety and effective treatment.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to wounds or damaged skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additional considerations include the recommendation for individuals who are pregnant or breastfeeding to seek advice from a healthcare professional prior to use. It is also crucial to keep this product out of reach of children; in the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (800-222-1222) should be made.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Healthwise Pain Relieving Cream (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. For children under 2 years of age, the use of this medication is not recommended; caregivers should consult a physician for guidance.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 health 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 not been specifically addressed in the drug insert text 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center at 800-222-1222 without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers monitor the patient closely for any symptoms that may arise and initiate appropriate management procedures based on the clinical presentation.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be informed not to use the product on wounds or damaged skin to avoid potential complications. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using the product, patients should be cautioned to avoid contact with the eyes and to refrain from bandaging the area tightly, as this may lead to adverse effects.

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, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)