PO Sum on Healing Balm

Description

PO SUM ON HEALING BALM is a topical formulation available in a dosage form of 0.35 oz (10 g). The product is identified by the National Drug Code (NDC) 54155-053-03.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as 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, 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 without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to ensure safety and appropriateness for this age group.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for exacerbating injury or delaying healing. Additionally, if excessive irritation develops, discontinuation of use is advised to prevent further skin damage. Contact with the eyes should be avoided to prevent irritation or injury. Tight bandaging is also contraindicated, as it may lead to compromised circulation or increased irritation.

Warnings and Precautions

For external use only. This product is not intended for application on wounds or damaged skin. Healthcare professionals should advise patients to discontinue use if excessive irritation develops.

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

Patients are instructed to stop using the product and consult a healthcare provider if any of the following occur: the condition worsens; symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if the product is being used for arthritis pain and any of the following conditions arise: pain persists for more than 10 days, redness is present, or if the patient is under 12 years of age.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if using the product for arthritis pain and any of the following apply: pain persists for more than 10 days, redness is present, or the product is being used in children under 12 years of age.

Drug Interactions

There are currently no documented drug interactions associated with 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 PO Sum on Healing Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

In pediatric patients under 12 years of age, it is important to discontinue use and seek medical advice if redness occurs or if pain persists for more than 10 days.

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 PO SUM ON HEALING BALM (menthol ointment) 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 of childbearing potential. 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 by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 context of overdosage, it is important to note that there is currently no information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and monitor patients closely, as the absence of specific overdosage data may necessitate individualized assessment and management strategies.

In the event of suspected overdosage, standard supportive measures should be implemented. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety. Healthcare providers should also consider consulting a poison control center or relevant toxicology resources for guidance on managing potential overdose scenarios.

As always, it is essential to adhere to established protocols and guidelines when addressing any medical emergencies, including overdosage situations.

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 through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number provided for this purpose.

Patient Counseling

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

Patients should be instructed not to use the product on wounds or damaged skin. They should also be informed to discontinue use if excessive irritation develops. If the condition worsens or if symptoms persist for more than 7 days, patients should be advised to stop using the product and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, patients should seek medical advice.

For those using the product for arthritis pain, it is important to inform patients to stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used for children under 12 years of age.

Patients should be cautioned to avoid contact with the eyes while using this product. Furthermore, they should be advised not to bandage the area tightly when applying the product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 15 to 30°C (59 to 86°F) to ensure optimal stability and efficacy. Proper handling and storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before 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 PO Sum on Healing Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)